Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA 084469 for Hydralazine Hydrochloride 50 mg Tablet (IVAX Sub Teva Pharm)
The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Leading Pharma’s Lorazepam Tablet ANDA078203
The FDA has approved ANDA078203 for Lorazepam tablets (0.5 mg, 1 mg, 2 mg) manufactured by Leading Pharma, LLC.
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Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Bausch & Lomb Ophthalmic Diclofenac Sodium 0.1% Solution (ANDA078792)
The FDA has approved Bausch & Lomb’s ophthalmic diclofenac sodium 0.1% solution (ANDA078792) for prescription use, confirming its safety and efficacy.
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Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA079186 for Dorzolamide Hydrochloride Ophthalmic Solution
FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA079164 for Flecainide Acetate Tablets by Chartwell RX
The FDA approved the abbreviated new drug application ANDA079164 for Flecainide Acetate tablets (50 mg, 100 mg, 150 mg) from Chartwell RX, though the products are currently listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Glenmark’s Carvedilol Generic Tablets (ANDA078251)
The FDA has granted labeling approval for Glenmark Pharmaceuticals’ generic carvedilol tablets (ANDA078251), available in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg oral dosage forms.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Chartwell Allopurinol Generic (ANDA077353)
FDA has approved Chartwell RX's generic allopurinol tablets (100 mg and 300 mg) under ANDA 077353, confirming prescription status and labeling updates.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA078979 for DIVALPROEX SODIUM
The FDA has approved application ANDA078979 for the oral delayed‑release capsule of DIVALPROEX SODIUM, manufactured by NorthStar Rx LLC and Dr. Reddy's Laboratories Ltd.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for Discontinued Chlorthalidone Tablet (ANDA 087292)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for the discontinued oral chlorthalidone 25 mg tablet (product 001, ANDA 087292).
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Alembic’s Nitrofurantoin Generic Capsules (ANDA211935)
The FDA has approved Alembic Pharmaceuticals’ generic Nitrofurantoin capsules (ANDA211935) for oral prescription use in 25 mg, 50 mg, and 100 mg strengths.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA212652 for Esomeprazole Magnesium Delayed‑Release Oral Suspension
The FDA has approved Torrent Pharmaceuticals' generic esomeprazole magnesium delayed‑release oral suspension (ANDA212652), a prescription oral drug with 10 mg base per packet.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA080279 for Prednisone 5mg Tablet by Inwood Labs
The FDA approved ANDA080279 for a 5 mg oral prednisone tablet submitted by Inwood Labs; the product is listed as discontinued.