Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA078902 for Paroxetine Hydrochloride Tablets
The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA077545 for Ondansetron Hydrochloride Tablets
FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves OSTEOSCAN (NDA 017454) as Radiopharmaceutical Injection
FDA granted priority approval to OSTEOSCAN, a technetium‑99m etidronate injectable, on Sep 28 1973; later supplemental filings updated labeling, manufacturing and efficacy. Product now discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NDA017421 for DIAL Topical Solution Containing 0.25% Hexachlorophene
The FDA granted approval (NDA017421) for DIAL’s discontinued topical solution containing 0.25% hexachlorophene.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Labeling and REMS Submissions for Discontinued OxyMorphone Hydrochloride ER Tablets (ANDA 079046)
The FDA records show OxyMorphone Hydrochloride extended‑release tablets are discontinued, yet several labeling and REMS submissions for the product have been approved.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Discontinues Oral CHLORPHENIRAMINE MALEATE Tablet (ANDA080786)
The FDA has marked the oral CHLORPHENIRAMINE MALEATE 4 mg tablet (product 001) from sponsor PVT FORM as discontinued under ANDA080786.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Labeling for ORETON Buccal Tablet (Methyltestosterone 10 mg) – ANDA080281
The FDA approved labeling for SCHERING's ORETON buccal tablet containing 10 mg methyltestosterone (application ANDA080281). The product is listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Zenara’s Aminocaproic Acid Injection (ANDA215374)
The FDA has granted approval for Zenara’s aminocaproic acid injectable (250 mg/mL) under ANDA215374, classified as a prescription product.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Assigns NDA 214937 for Helium Inhalation Product by Westair Gases
The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Grants ANDA214126 Approval for SUGAMMADEX SODIUM Intravenous Solutions
The FDA has approved Teva Pharm USA's ANDA214126 for two intravenous SUGAMMADEX SODIUM solutions (200 mg/2 mL and 500 mg/5 mL).
Regulatory Updates
Sep 12, 2026•1 min read
Laurus Labs Ltd Submits New Combination NDA 213696 to FDA
Laurus Labs Ltd filed a Type 4 New Combination NDA (213696) with the FDA, recorded as a standard priority original submission on Jan 25 2022.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves PHYTONADIONE (Vitamin K) Generic – ANDA213336
FDA granted approval for PHYTONADIONE tablets, a vitamin K generic from Agnitio Inc., under ANDA213336 on Oct 12, 2023.