Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Methyclothiazide Tablet (ANDA 088750)
The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 089107)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor PharmaFair as discontinued under ANDA 089107.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA 088119 for Isoniazid 300 mg Tablet
The FDA approved application ANDA088119 for an oral Isoniazid 300 mg tablet marketed by Duramed Pharms Barr. The product is listed as discontinued and includes a detailed submission history.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Records Show Discontinued BENEMID (Probenecid) Tablet with Multiple Priority Submissions
The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Lannett’s VELTANE 4 mg Oral Tablet (ANDA 084088)
The FDA has granted approval for Lannett’s generic VELTANE oral tablet containing 4 mg brompheniramine maleate (ANDA 084088).
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA083457 for MK Labs Vitamin A Capsules (Discontinued)
FDA approved ANDA083457 for MK Labs' oral Vitamin A capsule products, both listed as discontinued, with details on dosage strengths and submission date.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA081095 for Oral Acetaminophen/Aspirin/Codeine Capsule (Discontinued)
The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Lists ANDA080493 for Purepac CORTISONE ACETATE Oral Tablet (Discontinued)
The FDA entry ANDA080493 shows Purepac Pharm's oral CORTISONE ACETATE 25 mg tablet is listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva’s Methylphenidate Extended‑Release Capsules (ANDA 078873)
The FDA approved ANDA 078873 for Teva’s methylphenidate hydrochloride extended‑release capsules (40 mg, 50 mg, 60 mg). All listed products are currently discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for SLO‑BID (Theophylline 50 mg)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Diphynoxylate Hydrochloride/Atropine Sulfate Tablet (ANDA 087934)
FDA records show ASCOT's oral tablet containing diphenoxylate hydrochloride 2.5 mg and atropine sulfate 0.025 mg is listed as discontinued under ANDA 087934.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA087564 for Isosorbide Dinitrate Tablet
The FDA approved application ANDA087564 for Sun Pharm Industries' oral tablet Isosorbide Dinitrate 30 mg, listed with a discontinued marketing status.