Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 084279 for Probenecid and Colchicine Oral Tablet
The FDA has approved ANDA 084279 for a prescription oral tablet combining 500 mg probenecid and 0.5 mg colchicine, marketed by Actavis Pharma.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Issues ANDA084743 for Inwood Labs' Phendimetrazine Tartrate Tablet (Discontinued)
The FDA has listed ANDA084743 for Inwood Labs' oral tablet of Phendimetrazine Tartrate (35 mg), currently marked as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
TABLICAPS Submits ANDA085207 for Oral Reserpine 0.25 mg Tablet (Discontinued)
TABLICAPS has filed ANDA085207 for an oral 0.25 mg Reserpine tablet, which is listed with a discontinued marketing status.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 085702 for Phendimetrazine Tartrate Oral Capsule
Sandoz's oral capsule product PHENDIMETRAZINE TARTRATE (35 mg) under application ANDA085702 has received FDA approval; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues GUANETHIDINE MONOSULFATE Oral Tablet (ANDA 086114)
Watson Labs' oral tablet GUANETHIDINE MONOSULFATE (product 001) is listed as discontinued in FDA records under ANDA 086114.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Alprazolam Extended‑Release Tablets (ANDA077777)
FDA records show Sandoz's alprazolam extended‑release tablets (product numbers 001‑004) are discontinued, with multiple labeling supplement approvals.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Abbott's Calcium Gluceptate Injection (ANDA083159)
FDA approved Abbott's Calcium Gluceptate injection (ANDA083159) in 1972, with a supplemental manufacturing amendment in 1984; the product is now discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Piperazine Citrate Syrup (ANDA080774)
The FDA has listed the oral syrup product Piperazine Citrate (product 001) from Alpharma US Pharms as discontinued under ANDA080774.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Lists ANDA083760 for Watson Labs' Pyridoxine Hydrochloride Injection (Discontinued)
The FDA database shows an ANDA (application ANDA083760) submitted by Watson Labs for a pyridoxine hydrochloride injectable (100 mg/mL) that is currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA084351 for Brompheniramine Maleate 4 mg Tablet (Now Discontinued)
The FDA granted approval (ANDA084351) for a 4 mg oral tablet of brompheniramine maleate by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ACETAZOLAMIDE Oral Tablet (ANDA084840)
The FDA has approved an ANDA for ACETAZOLAMIDE 250 mg oral tablets, with original and multiple supplemental approvals for labeling and manufacturing from 1978 to 2016.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves KV PHARM Acetaminophen/Codeine Phosphate Tablet (ANDA085288)
FDA approved KV PHARM's oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate (ANDA085288). Multiple labeling submissions were filed; the product is now discontinued.
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