Regulatory Updates
Sep 17, 2026•1 min read
Cipla Submits ANDA077221 for Lamivudine Tablets (150 mg & 300 mg)
Cipla has an ANDA (application number ANDA077221) for lamivudine tablets in 150 mg and 300 mg strengths, with standard labeling submissions approved in 2019.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)
The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA076367 for Amcinonide Topical Ointment
FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 076648 for Nitrofurantoin Oral Capsules (Monohydrate/Macrocrystals)
The FDA granted approval for ANDA 076648, covering nitrofurantoin (75 mg + 25 mg macrocrystalline) oral capsules marketed by Chartwell Rx.
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Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Oxford Generic Amlodipine Besylate Tablets (ANDA078414)
FDA granted approval for ANDA078414, authorizing Oxford Pharmaceuticals' generic amlodipine besylate tablets in 2.5 mg, 5 mg, and 10 mg strengths.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)
The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Griseofulvin Oral Suspension (ANDA 065394)
The FDA has approved an oral suspension of griseofulvin (125 mg/5 mL) from Actavis Pharma under ANDA 065394.
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Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Minocycline Hydrochloride Tablets (ANDA 065131)
The FDA approved Strides Pharma's minocycline hydrochloride oral tablets (50 mg, 75 mg, 100 mg) under ANDA 065131, confirming prescription status.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA063264 for Amikacin Sulfate Injection
The FDA approved ANDA063264 for Amikacin Sulfate injectable by Hospira. The product is listed as discontinued and includes multiple labeling and manufacturing supplemental submissions.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves HIKMA ANDA062720 for Cephapirin Sodium Injection (Discontinued Products)
The FDA approved HIKMA's ANDA062720 for cephapirin sodium injectable products, all listed as discontinued, with approval dated July 2, 1987.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA071510 for Clorazepate Dipotassium Oral Capsule
The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Registers Manufacturing Submissions for Discontinued Ibuprofen Tablet (ANDA 071144)
The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.