Regulatory Updates
Sep 5, 2026•1 min read
FDA Lists Dextroamphetamine Sulfate Tablet (5 mg) as Discontinued – ANDA 086521
The FDA has marked the oral tablet product Dextroamphetamine Sulfate (5 mg) from sponsor MAST MM as discontinued under ANDA 086521.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA085964 for Acetaminophen and Codeine Phosphate Tablet
The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.
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
Quinapril Hydrochloride and Hydrochlorothiazide Tablets – FDA Labeling Approvals (ANDA 077093)
FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.
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 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
FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution
The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Approves ANDA090572 for Children’s Cetirizine Oral Solutions
FDA approved ANDA090572 submitted by Tris Pharma, covering two discontinued children’s cetirizine hydrochloride oral solutions for allergy and hives relief.
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.