Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Lupin ANDA209272 for Metoprolol Succinate ER Tablets
FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA210272 for Buprenorphine Transdermal Patch
The FDA has approved application ANDA210272 for a buprenorphine transdermal patch, covering five dosage strengths and requiring a REMS program.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA209953 for Ranolazine Extended‑Release Tablets
The FDA has approved ANDA209953 for generic Ranolazine extended‑release tablets (500 mg and 1 g) manufactured by Ascend Laboratories and sponsored by ALKEM LABS.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Lupin’s CYANOCOBALAMIN Nasal Spray
The FDA granted approval for Lupin Pharmaceuticals' prescription nasal spray containing 0.5 mg per spray of CYANOCOBALAMIN under ANDA210629.
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Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves Methylphenidate Hydrochloride Oral Solution (ANDA 207417)
FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Approves ANDA207047 for Clindamycin Palmitate Hydrochloride
The FDA has approved ANDA207047 for an oral clindamycin palmitate hydrochloride solution (75 mg/5 ml) marketed by Heritage Pharmaceuticals under sponsor APPCO.
Regulatory Updates
Sep 2, 2026•1 min read
FDA Grants ANDA206666 Approval for Pentamidine Isethionate Injection
FDA approved ANDA206666 for Pentamidine Isethionate injectable, a prescription drug administered intramuscularly or intravenously.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 084030 for Amosene 400 mg Meprobamate Tablet
The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA083389 for Lidocaine Hydrochloride with Epinephrine Injection (Discontinued)
The FDA approved ANDA083389 for a lidocaine hydrochloride 1% injection containing 0.01 mg/mL epinephrine, submitted by Dell Labs; the product is listed as discontinued.
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Regulatory Updates
Aug 31, 2026•1 min read
FDA ANDA089606: Watson Labs' PROCHLORPERAZINE EDISYLATE Injection Discontinued
The FDA’s ANDA089606 filing for Watson Labs’ prochlorperazine edisylate injectable is listed as discontinued, detailing route, dosage form, and active ingredient.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Discontinues ANDA089249 for NANDROLONE DECANOATE Injection
The FDA has listed the ANDA089249 application for NANDROLONE DECANOATE injectable by Quad Pharms as discontinued, noting its marketing status and product details.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 088872 for Thioridazine Hydrochloride Tablet (Discontinued)
The FDA has approved ANDA 088872 for an oral tablet of thioridazine hydrochloride (200 mg) submitted by Watson Labs Teva, though the product is listed as discontinued.