Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 077395 for Paroxetine Hydrochloride Oral Suspension (Discontinued)
The FDA approved ANDA 077395 for an oral suspension of Paroxetine Hydrochloride; the product is listed as discontinued and has a series of labeling supplement approvals.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 076802 for Glimepiride Tablets (Discontinued)
FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Labeling Updates for Discontinued Fenofibrate Tablet Products (ANDA 076520)
The FDA has approved a series of labeling submissions for three discontinued oral fenofibrate tablet products (54 mg, 107 mg, 160 mg) under ANDA 076520, with approvals spanning 2005‑2021.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 076251 for Fluoxetine Hydrochloride Capsules (Discontinued)
The FDA has approved ANDA 076251 submitted by Barr for fluoxetine hydrochloride oral capsules, 40 mg base, now listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA077991 for OTC Cetirizine/Pseudoephedrine Extended‑Release Tablet
The FDA has approved ANDA077991 for an over‑the‑counter oral tablet containing 5 mg cetirizine hydrochloride and 120 mg pseudoephedrine hydrochloride, submitted by PLD Acquisitions.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Apotex Latanoprost Ophthalmic Solution (ANDA077697)
The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.
Regulatory Updates
Sep 4, 2026•1 min read
King Pharm Discontinues Quinidine Sulfate Oral Tablet (ANDA 085175)
King Pharm's ANDA 085175 for quinidine sulfate 200 mg oral tablets is listed as discontinued by the FDA.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Approves ANDA078948 for Ibandronate Sodium Tablet
The FDA has approved ANDA078948 for a prescription oral tablet of Ibandronate Sodium 150 mg, sponsored by Apotex and manufactured by Golden State Medical Supply.
Regulatory Updates
Sep 4, 2026•1 min read
FDA ANDA080667 Submission for Thiamine Hydrochloride Injection (Discontinued)
The FDA received ANDA080667 from sponsor Luitpold for a thiamine hydrochloride injectable product, listed as discontinued.
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Regulatory Updates
Sep 4, 2026•1 min read
FDA Issues ANDA Approval for STILBESTROL Oral Tablet (Discontinued)
The FDA has approved ANDA083004 for STILBESTROL, an oral tablet containing 0.5 mg diethylstilbestrol, marketed by Tablicaps and listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves MK Labs SOSOL 500 mg Sulfisoxazole Oral Tablet (ANDA 080036) – Discontinued
The FDA approved ANDA 080036 for MK Labs' SOSOL oral tablet containing 500 mg sulfisoxazole. The product is listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
Cipla’s ABACAVIR SULFATE Oral Solution Receives Tentative FDA Approval (ANDA 078348)
The FDA has granted a tentative approval for Cipla Limited’s ABACAVIR SULFATE oral solution (20 mg) under ANDA 078348.
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