Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077941 for Injectable Furosemide (10 mg/mL) by Apotex
The FDA has granted approval (ANDA077941) for Apotex's injectable furosemide 10 mg/mL, classified as a prescription product.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling for PLASMA‑LYTE 56 and Dextrose 5% Injection (NDA 017385)
The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Dextrose 10% & Sodium Chloride 0.9% Injectable (Now Discontinued)
The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA216294 Approval for Calcitonin Salmon Injection by Amneal
The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA215856 for Furosemide Injection (10 mg/mL)
The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.
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Regulatory Updates
Sep 17, 2026•1 min read
FDA Grants ANDA Approval for ICATIBANT (ANDA213773)
FDA approved ANDA213773 for the subcutaneous injectable prescription drug ICATIBANT, manufactured by Alembic Pharmaceuticals.
Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA050306: Discontinued GEOPEN Injectable Carbenicillin Products
The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues HALOPERIDOL Injectable (ANDA070802)
The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Wellcovorin Injection (ANDA089465)
The FDA records show that the injectable product Wellcovorin, containing Leucovorin Calcium (50 mg per vial), has been marked as discontinued under ANDA089465.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sun Pharm ANDA077373 for Octreotide Acetate Injectable Products
FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 076235 for Carboplatin Injection (Fresenius Kabi USA)
The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Hikma Phenytoin Sodium Injection (ANDA 084307)
FDA has approved ANDA 084307 for Hikma Pharmaceuticals' generic phenytoin sodium injectable, available for intramuscular and intravenous use with multiple NDC listings.