Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA 084469 for Hydralazine Hydrochloride 50 mg Tablet (IVAX Sub Teva Pharm)
The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA083919 for MILTOWN Oral Tablet (Meprobamate 600 mg)
The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Discontinues Hydrocortisone 0.5% Ointment (ANDA084969)
The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Supplemental Approvals for Quinidine Sulfate Oral Tablet
The FDA records show multiple approved supplemental submissions for the discontinued 200 mg oral tablet of quinidine sulfate, covering manufacturing and labeling.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves Manufacturing Supplements for LIORESAL (baclofen) Tablets
The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves Hydroxyzine Hydrochloride Injection (ANDA 088184)
FDA approves ANDA 088184 for Hydroxyzine Hydrochloride injectable product by Fresenius Kabi USA, with multiple labeling and manufacturing submissions.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Discontinues Lactulose Oral/Rectal Solution (NDA017906)
The FDA has listed the Lactulose oral and rectal solution (product #001) as discontinued under NDA017906, sponsored by Solvay.
Regulatory Updates
Sep 28, 2026•1 min read
FDA ANDA Approval: Cyproheptadine Hydrochloride Oral Tablet (ANDA 087839)
Pioneer Pharm's ANDA 087839 for an oral tablet of cyproheptadine hydrochloride 4 mg is listed by the FDA with a discontinued marketing status.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA087463 for Oxycet (Oxycodone/Acetaminophen) Tablet
The FDA has approved ANDA087463 for the oral tablet Oxycet, containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen, manufactured by SpecGx LLC.
Regulatory Updates
Sep 28, 2026•1 min read
FDA Lists ANDA088515 for Discontinued Oral Tablet TRILITRON
The FDA’s database shows ANDA088515 for TRILITRON, an oral tablet containing pseudoephedrine HCl 60 mg and triprolidine HCl 2.5 mg, marketed by Newtron Pharms and currently discontinued.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA077903 for Zolpidem Tartrate
FDA grants approval for Torrent Pharmaceuticals' Zolpidem Tartrate oral tablets (5 mg and 10 mg) under ANDA077903, confirming prescription status and labeling updates.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA077302 for Actavis Extended‑Release Amphetamine Combination Capsules
The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.