Accelerated Revision History 2016-2020

2020 Archived Revisions

• <7> Labeling (posted 26–Apr–2019; official 01–May–2019) | En español
• <7> Labeling (posted 30–Aug–2019; official 01–Sep–2019) | En español
• <121> Insulin Assays (posted 29–Mar–2019; official 01–May–2019) | En español
• <795> Pharmaceutical Compounding—Nonsterile Preparations- Postponement (posted 22–Nov–2019; official 01–Dec–2019) | En español
• <797> Pharmaceutical Compounding—Sterile Preparations- Postponement (posted 22–Nov–2019; official 01–Dec–2019) | En español
• <800> Hazardous Drugs—Handling in Healthcare Settings (posted 31–May–2019, updated 27–Sep–2019; official 01–Dec–2019) | En español
• <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging-Postponement (posted 22–Nov–2019; official 01–Dec–2019) | En español
• <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples- Postponement (posted 22–Feb–2019; official 01–Mar–2019) | En español
• Abiraterone Acetate Tablets (posted 18–Nov–2019; official 19–Nov–2019) | En español
• Alprazolam Tablets (posted 22–Feb–2019; official 01–Mar–2019) | En español
• Amiodarone Hydrochloride Tablets (posted 25–Oct–2019; official 01–Dec–2019) | En español
• Aminocaproic Acid Tablets (posted 10–Dec–2019; official 11–Dec–2019) | En español
• Atorvastatin Calcium Tablets (posted 22–Nov–2019; official 01–Dec–2019) | En español
• Atorvastatin Calcium Tablets (posted 25–Jan–2019; official 01–Feb–2019) | En español
• Bendamustine Hydrochloride (posted 22–Feb–2019; official 01–Mar–2019) | En español 
• Benzethonium Chloride (posted 25–Jan–2019; official 01–Feb–2019) | En español
• Bupropion Hydrochloride Extended-Release Tablets (posted 25–Jan–2019; official 01–Feb–2019) | En español
• Calcium Acetate Capsules (posted 26–Apr–2019; official 01–May–2019) | En español
• Cidofovir (posted 31–May–2019; official 01–Jun–2019) | En español
• Clonidine Transdermal System (posted 31–May–2019; official 01–Jun–2019) | En español
• Cyclophosphamide for Injection (posted 25–Oct–2019; official 01–Nov–2019) | En español
• Diltiazem Hydrochloride Extended-Release Capsules (posted 26–Apr–2019; official 01–May–2019) | En español
• Divalproex Sodium Extended-Release Tablets (posted 18–Nov–2019; official 19–Nov–2019) | En español
• Donepezil Hydrochloride Tablets (posted 22–Feb–2019; official 01–Mar–2019) | En español
• Drospirenone and Ethinyl Estradiol Tablets (posted 29–Mar–2019; official 01–Apr–2019) | En español
• Erythromycin Delayed-Release Tablets (posted 24–Jul–2019; official 25–Jul–2019) | En español
• Esomeprazole Magnesium Delayed-Release Capsules (posted 26–Jul–2019; official 01–Aug–2019) | En español
• Estradiol Transdermal System (posted 22–Nov–2019; official 01–Dec–2019) | En español
• Fenofibrate Capsules (posted 26–Apr–2019; official 01–May–2019) | En español
• Fluticasone Propionate and Salmeterol Inhalation Powder (posted 07–Feb–2019; official 08–Feb–2019) 
• Glucagon for Injection (posted 25–Jan–2019; official 01–Feb–2019) | En español
• Indomethacin Suppositories (posted 22–Nov–2019; official 01–Dec–2019) | En español
• Insulin (posted 29–Mar–2019; official 01–May–2019) | En español
• Insulin Zinc Suspension (posted 29–Mar–2019; official 01–May–2019) | En español
• Iohexol (posted 26–Jul–2019; official 01–Aug–2019) | En español
• Isophane Insulin Suspension (posted 29–Mar–2019; official 01–May–2019) | En español
• Isosorbide Mononitrate Extended-Release Tablets (posted 27–Sep–2019; official 01–Oct–2019) | En español
• Itraconazcole Capsules (posted 31–May–2019; official 01–Aug–2019) | En español
• Lamotrigine Extended-Release Tablets (posted 25–Jan–2019; official 01–Feb–2019) | En español
• Levetiracetam Oral Solution (posted 22–Nov–2019; official 01–Dec–2019) | En español
• Levothyroxine Sodium Tablets (posted 27–Sep–2019; official 01–Oct–2019) | En español
• Manganese Sulfate Injection (posted 26–Jul–2019; official 01–Aug–2019) | En español
• Metformin Hydrochloride Extended-Release Tablets (posted 22–Feb–2019; official 01–Mar–2019) | En español
• Methotrexate Injection (posted 26–Apr–2019; official 01–May–2019) | En español
• Methylphenidate Hydrochloride Extended-Release Tablets (posted 26–Jul–2019; official 01–Aug–2019) | En español
• Methylphenidate Hydrochloride Extended-Release Tablets (posted 22–Nov–2019; official 01–Dec–2019) | En español
• Miconazole Nitrate (posted 26–Apr–2019; official 01–May–2019) | En español
• Minocycline Hydrochloride Extended-Release Tablets (posted 30–Aug–2019; official 01–Sep–2019) | En español
• Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets (posted 22–Feb–2019; official 01–Mar–2019) | En español
• Olmesartan Medoxomil Tablets (posted 18–Mar–2019; official 19–Mar–2019)
• Olmesartan Medoxomil Tablets (posted 30–Aug–2019; official 01–Sep–2019)
• Oxybutynin Chloride Extended-Release Tablets (posted 27–Sep–2019; official 01–Oct–2019) | En español
• Pantoprazole Sodium Delayed-Release Tablets (posted 26–Apr–2019; official 01–May–2019) | En español
• Penicillamine Capsules (posted 10–Jun–2019; official 11–Jun–2019) | En español
• Potassium Chloride Extended-Release Tablets (posted 31–Jul–2019; official 01–Aug–2019) | 
• Potassium Chloride Extended-Release Tablets (posted 20–Aug–2019; official 21–Aug–2019)
• Potassium Chloride Extended-Release Tablets (posted 30–Aug–2019; official 01–Sep–2019) | En español
• Prompt Insulin Zinc Suspension (posted 29–Mar–2019; official 01–May–2019) | En español
• ​​​​​​​Propafenone Hydrochloride Extended-Release Capsules (posted 07–Mar–2019; official 08–Mar–2019) | En español
• Pseudoephedrine Hydrochloride Extended-Release Tablets (posted 22–Feb–2019; official 01–Mar–2019) | En español
• Quetiapine Extended-Release Tablets (posted 29–Mar–2019; official 01–Apr–2019) | En español
• Quetiapine Extended-Release Tablets (posted 28–Dec–2018; official 01–Jan–2019) | En español
• Ropinirole Extended-Release Tablets (posted 28–Jun–2019; official 01–Jul–2019) | En español
• Rosuvastatin Tablets (posted 29–Mar–2019; official 01–Apr–2019) | En español
• Tadalafil Tablets (posted 25–Oct–2019; official 01–Nov–2019) | En español
• Taurine (posted 22–Feb–2019; official 01–Mar–2019) | En español 
• Telmisartan and Amlodipine Tablets (posted 25–Jan–2019; official 01–Feb–2019) | En español
• Tranexamic Acid Tablets (posted 26–Jul–2019; official 01–Aug–2019) | En español
• Triamcinolone Acetonide Nasal Spray (posted 25–Jan–2019; official 01–May–2019) | En español
• Vancomycin Injection (posted 28–Feb–2019; official 01–Mar–2019) | En español
• Ziprasidone Capsules (posted 27–Sep–2019; official 01–Oct–2019) | En español

2019 Archived Revisions

• Acetaminophen Oral Suspension (Postponement) (RB; official 01–Aug–2018)
• Amoxicillin Capsules (RB; official 01–May–2018) | En español
• Amoxicillin Tablets (RB; official 01–May–2018) | En español
• Aprepitant Capsules (RB; official 01–May–2018) | En español
• Atorvastatin Calcium Tablets (RB; official 01–May–2018) | En español
• Benzonatate Capsules (RB; official 01–Jul–2018)
• Bicalutamide Tablets (RB; official 01–Nov–2018) | En español
• Bumetanide Tablets (RB; official 01–May–2018) | En español
• Carbidopa and Levodopa Orally Disintegrating Tablets (RB; official 01–Jun–2018)
• Clomipramine Hydrochloride Capsules (RB; official 19–Jan–2018)
• Desloratadine Orally Disintegrating Tablets (RB; official 01–Dec–2018) | En español
• Diclofenac Sodium and Misoprostol Delayed-Release Tablets (IRA; official 01–Mar–2018)
• Diltiazem Hydrochloride Extended-Release Capsules (RB; official 12–Jun–2018)
• Doxycycline Capsules (RB; official 01–May–2018) | En español
• Doxycycline Tablets (RB; official 01–Apr–2018) | En español
• Doxycycline Hyclate Tablets (RB; official 01–Nov–2018) | En español
• Drosperinone and Ethinyl Estradiol Tablets (RB; official 01–Dec–2018) | En español
• Epoetin (RB; official 01–May–2018) | En español
• Esomeprazole Magnesium Delayed-Release Capsules (RB; official 01–Mar–2018) | En español
• Ezetimibe Tablets (RB; official 01–Feb–2018) | En español
• Fexofenadine Hydrochloride Tablets (RB; official 01–Nov–2018) | En español
• Fexofenadine Hydrochloride and Pseudoephedrine Extended-Release Tablets (RB; official 01–Jul–2018; updated 27–Jul–2018; official 01–Aug–2018)
• Galantamine Extended-Release Capsules (RB; official 01–Jan–2018) | En español
• Glycine (RB; official 01–Aug–2018)
• Indomethacin Extended-Release Capsules (RB; official 01–Dec–2017) | En español
• Isosorbide Mononitrate Extended-Release Tablets (RB; official 08–Oct–2018) 
• Lamotrigine Extended-Release Tablets (RB; official 01–May–2018) | En español
• Levetiracetam Extended-Release Tablets (RB; official 01–May–2018) | En español
• Levetiracetam Tablets (RB; official 01–Mar–2018) | En español
• Levocetirizine Dihydrochloride (IRA; official 01–Jan–2018)  | En español
• Metformin Hydrochloride Extended-Release Tablets (RB; official 24–Sep–2018)
• Metoprolol Succinate Extended-Release Tablets (RB; official 01–Aug–2018)
• Metoprolol Succinate Extended-Release Tablets (RB; official 01–Dec–2018) | En español
• Morphine Sulfate Extended-Release Capsules (RB; official 01–Nov–2018) | En español
• Moxidectin (RB; official 27–Jun–2018)
• Naproxen Sodium Tablets (IRA; official 01‒May‒2018; updated 27–Oct–2017*)
  • *The IRA for Naproxen Sodium Tablets was updated on October 27, 2017 to change the official date of the revision from November 1, 2017 to May 1, 2018. In addition, clarifications were made to the calculations statement and Sample stock solution under Organic Impurities section.
• Nevirapine Extended-Release Tablets (RB; official 01–May–2018) | En español
• Niacin Extended-Release Tablets (RB; official 01–Jan–2018) | En español
• Nitrofurantoin Capsules (RB; official 01–Jun–2018)
• Nitrofurantoin Capsules (RB; official 01–Jan–2019) | En español
• Olmesartan Medoxomil Tablets (RB; official 01–Nov–2018) | En español
• Ondansetron Compounded Topical Gel (RB; official 01–Jun–2018)
• Oxybutynin Chloride Extended-Release Tablets (RB; official 01–Apr–2018) | En español
• Potassium Chloride Extended-Release Capsules (RB; official 01–Sep–2018)
• Prasugrel Hydrochloride (RB; official 01–Oct–2018)
• Raloxifene Hydrochloride Tablets (RB; official 01–Feb–2018) | En español
• Ritonavir Capsules (RB; official 01–Apr–2018) | En español
• Rivastigmine Tartrate Capsules (RB; official 01–Feb–2018) | En español
• Rosuvastatin Tablets (RB; official 01–Aug–2018)
• Salix Species Bark (IRA; official 01–Mar–2018) | En español
• Salix Species Bark Powder (IRA; official 01–Mar–2018) | En español
• Salix Species Bark Dry Extract (IRA; official 01–Mar–2018) | En español
• Tacrolimus Capsules (RB; official 01–Aug–2018)
• Telmisartan and Amlodipine Tablets (RB; official 01–Nov–2018) | En español
• Telmisartan and Hydrochlorothiazide Tablets (RB; official 01–Feb–2018) | En español
• Trazadone Hydrochloride Tablets (RB; official 01–Apr–2018) | En español
• Ziprasidone Capsules (RB; official 01–May–2018) | En español

2018 Archived Revisions

• <381> Elastomeric Closures for Injections (RB; official 01–Jan–2018) | En español
• <659> Packaging and Storage Requirements RB; official 01‒May‒2017; updated 26‒May‒2017)| En español
• ​​​​​​<661> Plastic Packaging Systems and Their Materials of Construction (RB; official 01‒May‒2017; updated 26‒May‒2017) | En español
• <661.1> Plastic Materials of Construction (RB; official 01‒May‒2017; updated 26‒May‒2017)  | En español
• <661.2> Plastic Packaging Systems for Pharmaceutical Use (RB; official 01‒May‒2017; updated 26‒May‒2017)  | En español
• <800> Hazardous Drugs–Handling in Healthcare Settings (RB; official 01–Dec–2017) | En español
• Almotriptan Tablets (RB; official 01–Feb–2017)
• Amlodipine and Valsartan Tablets (IRA; official 01–Nov–2017)
• Amlodipine, Valsartan, and Hydrochlorothiazide Tablets (IRA; official 01–Nov–2017)
• Anastrozole Tablets (IRA; official 01–Mar–2017)
• Aripiprazole Tablets (RB; official 01–Oct–2017)
• Aspirin, Alumina, and Magnesia Tablets (IRA; official 01–Jan–2017)
• Aspirin Boluses (IRA; official 01–Jan–2017)
• Aspirin Delayed-Release Capsules (IRA; official 01–Jan–2017)
• Aspirin Delayed-Release Tablets (IRA; official 01–Jan–2017)
• Aspirin Effervescent Tablets for Oral Solution (IRA; official 01–Jan–2017)
• Aspirin Extended-Release Tablets (IRA; official 01–Jan–2017)
• Aspirin Tablets (IRA; official 01–Jan–2017)
• Buffered Aspirin Tablets (IRA; official 01–Jan–2017)
• Bupropion Hydrochloride Extended Release Tablets (RB; official 01‒June‒2017)
• Buproprion Hydrochloride Extended Release Tablets (RB; official 01–Nov–2017)
• Bupropion Hydrochloride Extended-Release Tablets (RB; official 01–Nov–2017)
• Candesartan Cilexetil Tablets (RB; official 01–Dec–2016)
• Carbidopa and Levodopa Tablets (RB; official 01–Feb–2017) | En español
• Cetylpyridinium Chloride (Postponement) (RB; official 01‒Aug‒2017)
• Chondroitin Sulfate Sodium, Shark (RB; official 01–Feb–2017) | En español
• Cidofovir Injection (RB; official 01–Nov–2017)
• Clarithromycin Extended-Release Tablets (RB; official 01–Feb–2017) | En español
• Clindamycin Phosphate (RB; official 01‒May‒2017) | En español
• Dextromethorphan (RB; official 01–Mar–2017; updated 30–Dec–2016) | En español
• Dextromethorphan Hydrobromide (RB; official 01–Mar–2017; updated 30–Dec–2016) | En español
• Diltiazem Hydrochloride Extended-Release Capsules (RB; official 10–Oct–2017)
• Diltiazem Hydrochloride Extended-Release Capsules (RB; official 01–Dec–2017) | En español; 
• Diphenhydramine Hydrochloride Capsules (RB; official 01–May–2016)
• Diphenhydramine Hydrochloride Oral Solution (RB; official 01–May–2016)
• Diphenhydramine and Phenylephrine Hydrochlorides Tablets (RB; official 01–May–2016)
• Donepezil Hydrochloride Tablets (RB; official 01–Feb–2017) | En español
• Doxycycline Capsules (RB; official 01‒June‒2017)
• Doxycycline Capsules (RB; official 01–May–2018) | En Español
• Doxycycline Hyclate Capsules (RB; official 01‒May‒2017) | En español
• Doxycycline Hyclate Delayed-Release Tablets (RB; official 01‒Aug‒2017)
• Doxycycline Hyclate Tablets (RB; official 01‒May‒2017) | En español
• Doxycycline Hyclate Tablets (RB; official 01‒Aug‒2017)
• Doxorubicin Hydrochloride Injection (IRA; official 01–Mar–2017)
• Duloxetine Delayed-Release Capsules (RB; official 01‒Aug‒2017)
• Dutasteride (RB; official 01–Feb–2017) | En español
• Dutasteride (RB; official 01–Jan–2018) | En español
• Entecavir Tablets (RB; official 01–Feb–2017) | En español
• Eprinomectin (IRA; official 01–Jan–2017)
• Estradiol Transdermal Systems (RB; official 01–Feb–2017) | En español
• Eszopiclone Tablets (RB; official 01‒Aug‒2017)
• Fenofibrate Tablets (RB; official 01–Dec–2016)
• Fenofibrate Capsules (RB; official 01–Nov–2017)
• Isoleucine (RB; official 01‒Aug‒2017)
• Lamotrigine Extended-Release Tablets (IRA; official 01–Dec–2016)
• Lamotrigine Extended-Release Tablets (RB; official 01–Nov–2017)
• Leucine (RB; official 01‒Aug‒2017)
• Levetiracetam Extended-Release Tablets (RB; official 01–Nov–2017)
• Methylphenidate Hydrochloride Extended-Release Tablets (RB; official 01–Apr–2017) | En español
• Methyl Salicylate (RB; official 01‒Aug‒2017)
• Montelukast Sodium Oral Granules (RB; official 01–Oct–2017)
• Montelukast Sodium Chewable Tablets (RB; official 01–May–2016)
• Montelukast Sodium Oral Granules (RB; official 01–May–2016)
• Montelukast Sodium Tablets (RB; official 01–May–2016)
• Moxifloxacin Hydrochloride (RB; official 01‒Aug‒2017)
• Naproxen Sodium Tablets (IRA; official 01–May–2018)
• Niacin Extended-Release Tablets (RB; official 01–Feb–2017) | En español
• Nicotine Polacrilex (Postponment) (RB; official 01‒May‒2017) | En español
• Nifedipine Extended-Release Tablets (RB; official 01‒Aug‒2017)
• Nifedipine Extended-Release Tablets (RB; official 01–Oct–2017)
• Norethindrone and Ethinyl Estradiol Tablets (RB; official 01–Nov–2017)
• Olmesartan Medoxomil Tablets (RB; official 01‒Aug‒2017
• Octyldodecanol (IRA; official 01–Jan–2017)
• Oxybutynin Chloride Extended-Release Tablets (RB; official 01‒Aug‒2017)
• Oxybutynin Chloride Extended-Release Tablets (RB; official 01–Nov–2017)
• Oxymorphone Hydrochloride Extended-Release Tablets (RB; official 01–Dec–2016)
• Oxymorphone Hydrochloride Tablets (RB; official 01–Dec–2016)
• Oxymorphone Hydrochloride Extended-Release Tablets (RB; official 01–Feb–2017) | En español
• Paroxetine Extended-Release Tablets (RB; official 01–Feb–2017) | En español
• Phenylephrine Hydrochloride Tablets (RB; official 01–May–2016)
• Phenoxybenzamine Hydrochloride Capsules (RB; official 01‒Aug‒2017)
• Phenoxybenzamine Hydrochloride Capsules (RB; official 01–Oct–2017)
• Potassium Citrate Extended-Release Tablets (RB; official 01–Apr–2017) | En español
• Promethazine Hydrochloride Oral Solution (RB; official 01–Feb–2017) | En español
• Promethazine Hydrochloride Injection (RB; official 01‒June‒2017) 
• Propafenone Hydrochloride Extended-Release Capsules (RB; official 01–Jun–2016)
• Pyridostigmine Bromide Tablets (IRA; official 01–Nov–2017)
• Quetapine Extended-Release Tablets (RB; official 01–Nov–2017)
• Quinine Sulfate Capsules (RB; official 01–Feb–2017) | En español
• Ribavarin Capsules (RB; official 01–Jun–2016)
• Ropirinole Extended-Release Tablets (RB; official 01–Nov–2017)
• Salix Species Bark (Postponment) (RB; official 01‒Dec‒2017)
• Salix Species Bark Dry Extract (Postponment) (RB; official 01‒Dec‒2017)
• Salix Species Bark Powder (Postponment) (RB; official 01‒Dec‒2017)
• Salmeterol Xinafoate (RB; official 01‒Aug‒2017)
• Selamectin (Postponment) (RB; official 01‒May‒2017) | En español
• Sulindac Tablets (IRA; official 01–Jul–2017)
• Tamsulosin Hydrochloride Capsules (RB; official 01–Jun–2016)
• Telmisartan Tablets (RB; official 01–Nov–2017)–2017)
• Theophylline Oral Solution (RB; official 01–Feb
• Tolterodine Tartrate (RB; official 01–Aug–2017)
• Topiramate (IRA; official 01–May–2017)
• Tramadol Hydrochloride Extended-Release Tablets (RB; official 01–Jun–2016)
• Valine (RB; official 01– Aug–2017)
• Ziprasidone Capsules (RB; official 01–Nov–2017)
• Zolmitriptan Tablets (RB; official 01–Nov–2017)

2017 Archived Revisions

• <1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests (RB; official 01–May–2016) | En español
• <2251> Adulteration of Dietary Supplements with Drugs and Drug Analogs (RB; official 01–Aug–2016) | En español
• Alfuzosin Hydrochloride Extended-Release Tablets (RB; official 01–Jun–2016)
• Amlodipine and Valsartan Tablets (RB; official 01–Jun–2016)
• Amlodipine, Valsartan, and Hydrochlorothiazide Tablets (RB; official 01–Jun–2016)
• Apripiprazole Tablets (RB; official 01–Jun–2016) En español
• Aspartic Acid (IRA; official 01–Sep–2016)
• Atropine Sulfate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Bacitracin Ophthalmic Ointment (RB; official 01–Aug–2016)
• Bacitracin Zinc and Polymixin B Sulfate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Beta Carotene Preparation (RB; official 01–Feb–2016)
• Bland Lubricating Ophthalmic Ointment (RB; official 01–Aug–2016)
• Bupropion Hydrochloride Extended-Release Tablets (RB; official 01–Aug–2016)
• Ceftriaxone Sodium (IRA; official 01–Aug–2016; updated 06–Jul–2016*)
  *The Ceftriaxone Sodium IRA posted on June 24, 2016 had the incorrect official date. The IRA was reposted on July 6, 2016 with the correct official date of August 1, 2016.
• Ceftriaxone for Injection (IRA; official 01–Aug–2016; updated 06–Jul–2016**)
  **The incorrect version of the Ceftriaxone for Injection IRA was posted on June 24, 2016. A corrected Ceftriaxone for Injection IRA was posted on July 6, 2016, which includes revisions to Table 1 in the Organic Impurities section. In addition the official date was corrected to be August 1, 2016.
• Cetylpyridinium Chloride (RB; official 01–Aug–2016)
• Chloramphenicol and Polymixin B Sulfate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Chloramphenicol Ophthalmic Ointment (RB; official 01–Aug–2016)
• Chlortetracyline Hydrochloride Ophthalmic Ointment (RB; official 01–Aug–2016)
• Ciprofloxacin Ophthalmic Ointment (RB; official 01–Aug–2016)
• Cisatracurium Besylate (IRA; official 01–Jul–2016)
• Corticotropin Injection (IRA; official 01–Jul–2016)
• Corticotropin for Injection (IRA; official 01–Jul–2016)
• Respository Corticotropin Injection (IRA; official 01–Jul–2016)
• Cyanocobalamin (RB; official 01–Jun–2016) En español
• Cyclobenzaprine Hydrochloride Tablets (RB; official 01–Feb–2016)
• Dexamethasone Sodium Phosphate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Dextromethorphan (RB; official 01–Mar–2017)
• Dicloxacillin Sodium (RB; official 01–Aug–2016)
• Diphenoxylate Hydrochloride (RB; official 01–Feb–2016)
• Divalproex Sodium Delayed-Release Capsules (RB; official 01–Feb–2016)
• Divalproex Sodium Delayed-Release Capsules (RB; official 01–Aug–2016)
• Docetaxel (RB; official 01–Aug–2016)
• Dutasteride (IRA; official 01–Mar–2016)
• Dutasteride (RB; official 01–Jun–2016)
• Erythromycin Ophthalmic Ointment (RB; official 01–Aug–2016)
• Esomeprazole Magnesium (RB; official 01–Apr–2016)
• Esomeprazole Magnesium Delayed-Release Capsules (RB; official 01–Oct–2016)
• Estradiol and Norethindrone Acetate Tablets (IRA; official 01–Dec–2016)
• Extended Phenytoin Sodium Capsules (RB; official 01–Oct–2016)
• Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets (RB; official 01–Apr–2016)
• Galantamine Tablets (RB; official 01–Jan–2016)
• Galantamine Extended-Release Capsules (RB; official 01–Jun–2016)
• Gentamicin Sulfate Ophthalmic Ointment (RB; official 01–Aug–2016
• Gentamicin and Prednisolone Acetate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Glyceryl Tristearate (IRA; official 01–Jul–2016)
• Hydrocortisone Acetate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Idoxuridine Ophthalmic Ointment (RB; official 01–Aug–2016)
• Isoleucine (RB; official 01–Aug–2016)
• Insulin Glargine (IRA; official 01–Nov–2016)
• Insulin Glargine Injection (IRA; official 01–Nov–2016)
• Isotretenoin Capsules (RB; official 01–Feb–2016)
• Ketorolac Tromethamine (IRA; official 01–May–2016)
• Lamotrigine Extended-Release Tablets (RB; official 01–Dec–2016)
• Leucine (RB; official 01–Aug–2016)
• Levetiracetam Extended-Release Tablets (RB; official 01–Apr–2016)
• Levetiracetam Extended-Release Tablets (RB; official 01–Oct–2016)
• Levoceterizine Hydrochloride (RB; official 01–Apr
• Levothyroxine Sodium Tablets (IRA; official 01–Sep–2016)
• Liothyronine Sodium (IRA; official 01–Sep–2016)
• Levothyroxine Sodium Tablets (IRA; official 01–Sep–2016)
• Liothyronine Sodium (IRA; official 01–Sep–2016)
• Loperamide Hydrochloride Tablets (RB; official 01–Oct–2016)
• Losartan Potassium and Hydrochlorothiazide (RB; official 01–Jun–2016)
• Memantine Hydrochloride Tablets (RB; official 01–Apr–2016)
• Methocarbamol (IRA; official 01–Jan–2016)
• Methocarbamol Tablets (RB; official 01–Apr–2016)
• Methylene Blue Injection (RB; official 01–Nov–2016)
• Methylphenidate Hydrochloride Extended-Release Tablets (IRA; official 01–Mar–2016)
• Methylphenidate Hydrochloride Extended-Release Tablets (RB; official 01–Oct–2016)
• Moexepril Hydrochloride (RB; official 01–Jun–2016)
• Moexepril Hydrochloride Tablets (RB; official 01–Jun–2016)
• Montelukast Sodium Oral Granules (RB; official 01–Oct–2016)
• Neomycin Sulfate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Neomycin and Polymixin B Sulfates Ophthalmic Ointment (RB; official 01–Aug–2016)
• Neomycin and Polymixin B Sulfates and Bacitracin Ophthalmic Ointment (RB; official 01–Aug–2016)
• Neomycin and Polymixin B Sulfates, Bacitracin, and Hydrocortisone Acetate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Nitrofurantoin Capsules (RB; official 01–Oct–2016)
• Norethindrone Acetate Tablets (RB; official 01–Oct–2016)
• Omega-3-Ethyl Esters Capsules (IRA; official 01–Jan–2016)
• Omega-3-Ethyl Esters (IRA; official 01–Jan–2016)
• Orphenadrine Citrate Extended-Release Tablets (RB; official 01–Aug–2016)
• Oxybutynin Chloride Extended-Release Tablets (RB; official 01–Aug–2016)
• Oxymorphone Hydrochloride Extended-Release Tablets (RB; official 01–Dec–2016)
• Oxymorephone Hydrochloride Tablets (RB; official 01–Dec–2016)
• Oxytetracycline Hydrochloride and Polymixin B Sulfate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Pimozide (IRA; official 01–Nov–2016)
• Pimozide Tablets (IRA; official 01–Nov–2016)
• Propafenone Hydrochloride Extended-Release Capsules (RB; official 01–Oct–2016)
• Protamine Sulfate (IRA; official 01–Jul– 2016)
• Protamine Sulfate Injection (IRA; official 01–Jan–2016)
• Sodium Chloride Ophthalmic Ointment (RB; official 01–Aug–2016)
• Sulfacetamide Sodium Ophthalmic Ointment (RB; official 01–Aug–2016)
• Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment (RB; official 01–Aug–2016)
• Tamsulosin Hydrochloride (IRA; official 01–Sep–2016)
• Tetracycline Hydrochloride Ophthalmic Ointment (RB; official 01–Aug–2016)
• Tobramycin and Dexamethasone Ophthalmic Ointment (RB; official 01–Aug–2016)
• Tobramycin Ophthalmic Ointment (RB; official 01–Aug–2016)
• Tramadol Hydrochloride Extended-Release Tablets (RB; official 01–Aug–2016)
• Valine- Postponement (RB; official 01–May–2016)
• Valine (RB; official 01–Aug–2016)

2016 Archived Revisions

• <87> Biological Reactivity Tests, in Vitro (IRA; official 01–Nov–2015)
• <121> Insulin Assays (IRA; official 01–Mar–2015)
• Allopuriol (RB; official 01–Jun–2015)
• Aluminum  Sulfate and Calcium Acetate Topical Solution (IRA; official 01–Jul–2015)
• Dexamethasone Sodium Phosphate Cream (IRA; official 01–May–2015)
• Dexamethasone Sodium Phosphate Ophthalmic Ointment (IRA; official 01–May–2015)
• Dexamethasone Sodium Phosphate Ophthalmic Solution (IRA; official 01–May–2015)
• Digoxin (IRA; official 01–Nov–2015)
• Divalproex Sodium Delayed-Release Capsules (RB; official 01–Apr–2015)
• Ganoderma Lucidum Fruiting Body (IRA; official 01–Mar–2015)
• Ganoderma Lucidum Fruiting Body Powder (IRA; official 01–Mar–2015)
• General Notices and Requirements: Section 5.60.30 related to Elemental Impurities (RB; official 01–Apr–2015)
• Calcitonin Salmon Injection (IRA; official 01–Jan–2015)
• Calcitonin Salmon Nasal Solution (IRA; official 01–Jan–2015)
• Chondroitin Sulfate Sodium (RB; official 01–Jun–2015)
• Desoxycortisone Pivalate Injectable Suspension (RB; official 01–Feb–2015)
• Fosphenytoin Sodium Injection (RB; official 01–Feb–2015)
• Ketorolac Tromethamine Tablets (RB; official 01–Feb–2015)
• Letrozole Tablets (RB; official 01–Apr–2015)
• Menthol (RB; official 01–Jun–2015)
• Methocarbamol (RB; official 01–May–2015)
• Methocarbamol Tablets (RB; official 01–May–2015)
• Neomycin Sulfate and Dexamethasone Sodium Phosphate Cream (IRA; official 01–May–2015)
• Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment (IRA; official 01–May–2015)
• Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Solution (IRA; official 01–May–2015)
• Olanzapine Tablets (RB; official 01–Dec–2015)
• Oxycodone Hydrochloride (IRA; official 01–Nov–2015
• Oxycodone Hydrochloride Oral Solution (RB; official 01–Feb–2015)
• Propofol Injectable Emulsion (RB; official 01–Jun–2015)
• Protamine Sulfate Injection (RB; official 01–Jun–2015)
• Quetiapine Tablets (RB; official 01–Nov–2015)
• Raloxifene Hydrochloride Tablets (RB; official 01–Apr–2015)
• Ritonavir (RB; official 01–Jun–2015)
• Sesame Oil (IRA; official 01–Jul–2015) 
• Telmisartan and Hydrochlorothiazide Tablets (RB; official 01–Apr–2015)
• Trazodone Hydrochloride (RB; official 01–Feb–2015)