New Pending Notices of Intent Revise:
- Lacosamide (posted 28–May–2021)
- Metformin Hydrochloride Extended-Release Tablets (posted 28–May–2021)
- Methylprednisolone Sodium Succinate for Injection (posted 28–May–2021)
- Metoprolol Succinate Extended-Release Tablets (posted 30–Apr–2021)
- Diatrizoate Meglumine and Diatrizoate Sodium Solution (posted 26–Mar–2021)
Pending Notices of Intent to Revise:
- Abiraterone Acetate Tablets (posted 25–Jan–2019)
- Amlodipine and Olmesartan Medoxomil Tablets (posted 24–Apr–2020)
- Aminocaproic Acid Oral Solution (posted 31–Jan–2020)
- Azithromycin Tablets (posted 25–Jan–2019)
- Bupropion Hydrochloride Extended-Release Tablets (posted 26–Dec–2019)
- Carbamazepine Tablets (posted 26–Feb–2021)
- Carbidopa and Levodopa Extended-Release Tablets (posted 26–Oct–2018)
- Diatrizoate Meglumine Sodium Solution (posted 26–Mar–2021)
- Diclofenac Sodium and Misoprostol Delayed-Release Tablets (posted 29–Mar–2019)
- Dihydroergotamine Mesylate Injection (posted 24–Apr–2020)
- Diltiazem Hydrochloride Extended-Release Capsules (posted 31–Jul–2020)
- Doxycycline Capsules (posted 24–Apr–2020)
- Dronedarone Tablets (posted 28–Dec–2018)
- Dronedarone Tablets (posted 29–May–2020)
- Entacapone Tablets (posted 29–Mar–2019)
- Estradiol Transdermal System (posted 28–Sep–2018)
- Estradiol Transdermal System (posted 29–May–2020)
- Extended Phenytoin Sodium Capsules (posted 26–Apr–2019)
- Lacosamide (posted 28–May–2021)
- Lamotrigine Extended-Release Tablets (posted 28–Sep–2018)
- Lauroyl Polyoxylglycerides (posted 19–Feb–2021)
- Lamotrigine Extended-Release Tablets (posted 25–Jan–2019)
- Levothyroxine Sodium Tablets (posted 28–Feb–2020)
- Levothyroxine Sodium Tablets (posted 24–Apr–2020)
- Metformin Hydrochloride Extended-Release Tablets (posted 28–Sep–2018)
- Metformin Hydrochloride Extended-Release Tablets (posted 31–May–2019; updated 04–Jun–2019)
- Metformin Hydrochloride Extended-Release Tablets (posted 22–Nov–2019)
- Metformin Hydrochloride Extended-Release Tablets (posted 31–Jan–2020)
- Metformin Hydrochloride Extended-Release Tablets (posted 29–May–2020)
- Metformin Hydrochloride Extended-Release Tablets (posted 28–May–2021)
- Methylprednisolone Sodium Succinate for Injection (posted 28–May–2021)
- Metolazone Tablets (posted 18–Dec–2020)
- Metoprolol Succinate Extended-Release Tablets (posted 26–Jan–2018)
- Metoprolol Succinate Extended-Release Tablets (posted 26–Dec–2019)
- Metoprolol Succinate Extended-Release Tablets (posted 30–Apr–2021)
- Methylphenidate Hydrochloride Extended-Release Tablets (posted 27–Jul–2018)
- Methylphenidate Hydrochloride Extended-Release Tablets (posted 25–Jan–2019)
- Minocycline Hydrochloride Extended-Release Tablets (posted 29–Mar–2019)
- Nicardipine Hydrochloride Injection (posted 26–Oct–2018)
- Nitrofurantoin Capsules (posted 30–Aug–2019)
- Olmesartan Medoxomil Tablets (posted 26–Jul–2019)
- Omeprazole Delayed-Release Capsules (posted 26–Dec–2019)
- Pemetrexed Disodium (posted 29–Jan–2021)
- Propranalol Hydrochloride Extended-Release Capsules (posted 27–Mar–2020)
- Pyrazinamide (posted 19–Feb–2021)
- Quetiapine Extended-Release Tablets (posted 29–May–2020)
- Quetiapine Extended-Release Tablets (posted 18–Dec–2020)
- Quinidine Gluconate Extended-Release Tablets (posted 26–Feb–2021)
- Rufinamide Tablets (posted 28–Feb–2020)
- Sitagliptin Phosphate (posted 24–Apr–2020)
- Sitagliptin Phosphate (posted 28–Aug–2020)
- Tacrolimus Capsules (posted 30–Nov–2018)
- Tacrolimus Capsules (posted 20–Nov–2020)
- Teriparatide (posted 29–May–2020)
- Teriparatide Injection (posted 29–May–2020)
- Thalidomide Capsules (posted 26–Apr–2019)
- Vancomycin Injection (posted 26–Jun–2020)
- Zolmitriptan Nasal Spray (posted 24–Apr–2020)