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 DIVALPROEX SODIUM (ANDA078853)
FDA grants approval for DIVALPROEX SODIUM tablets (ANDA078853) by Bionpharma Inc., with oral delayed‑release 125 mg, 250 mg and 500 mg equivalents.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA077947 for Fluconazole Injectable Products (Discontinued)
The FDA has approved ANDA077947 submitted by Baxter Healthcare Corp for two discontinued Fluconazole injectable products in 0.9% sodium chloride, strengths 200 mg/100 mL and 400 mg/200 mL.
Regulatory Updates
Sep 25, 2026•1 min read
FDA ANDA077657: Lorazepam Tablet Discontinuations and Submission History
The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA077060 for Metformin Hydrochloride Extended‑Release Tablet by Zydus Lifesciences
The FDA has granted approval for ANDA077060, authorizing the prescription extended‑release metformin hydrochloride tablet (500 mg) marketed by Zydus Lifesciences.
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Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 076768 for Alendronate Sodium Tablets
The FDA has granted approval for an Abbreviated New Drug Application (ANDA) 076768 covering multiple strengths of alendronate sodium tablets, manufactured by Exelan Pharmaceuticals and Cipla USA.
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 ANDA 084031 for Sulfisozole 500 mg Oral Tablet (Discontinued)
The FDA granted approval (ANDA 084031) for BARR's sulfisozole 500 mg oral tablet, which is listed as discontinued. A labeling supplement was filed in 1995.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Labeling for Discontinued Enalapril/Hydrochlorothiazide ANDA076486
FDA records show that MPP Pharma's ANDA076486 for two oral enalapril maleate/hydrochlorothiazide tablets received multiple labeling approvals, but both products are listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves AMMONIUM LACTATE Topical Lotion (ANDA 076216)
The FDA has approved a prescription topical lotion containing 12% ammonium lactate, submitted under ANDA 076216 by Sun Pharma Canada.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Dexamethasone Sodium Phosphate Injection (ANDA 084282)
The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA080713 for TripeLennaMine Hydrochloride Tablet (Discontinued)
The FDA approved ANDA080713 for Watson Labs' oral tablet TripeLennaMine Hydrochloride 50 mg, now listed as discontinued, with a history of multiple supplemental approvals.