Regulatory Updates
Sep 8, 2026•1 min read
FDA Lists Watson Labs' Meclizine Hydrochloride 12.5 mg Tablet (ANDA 085195) as Discontinued
The FDA’s ANDA 085195 for Watson Labs’ oral Meclizine Hydrochloride 12.5 mg tablet is marked discontinued, indicating the product is no longer marketed.
Regulatory Updates
Sep 8, 2026•1 min read
FDA ANDA084259 for Methocarbamol 500 mg Oral Tablet (Mylan) – Discontinued
The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
Hydroxyzine Hydrochloride 50 mg Tablet Discontinued – FDA Submission History
FDA records indicate the oral Hydroxyzine Hydrochloride 50 mg tablet (product 001) is discontinued, with multiple manufacturing and labeling submissions approved between 1989 and 2016.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Labeling Updates for Chartwell Rx’s Discontinued Desloratadine Tablet (ANDA078364)
The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues Isoniazid Oral Tablet (ANDA083632)
The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues ANDA 080086 for Triple Sulfa Oral Tablet by Purepac Pharm
The FDA has listed the ANDA 080086 submission for the oral tablet Triple Sulfa, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
CHLORPROMAZINE HYDROCHLORIDE ANDA084113 FDA Approval
FDA approved ANDA084113 for chlorpromazine hydrochloride 50 mg oral tablets, manufactured by Upsher‑Smith Laboratories, LLC.
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 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 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.