Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA090137 for Sandoz Irinotecan Hydrochloride Injection
FDA approved Sandoz's ANDA090137 covering two Irinotecan Hydrochloride injectable products, both listed with discontinued marketing status.
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Regulatory Updates
Sep 25, 2026•1 min read
FDA ANDA077657: Lorazepam Tablet Discontinuations and Submission History
The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues Furosemide Injectable (NDA018025) after Multiple Submissions
The FDA record for NDA018025 shows the injectable form of furosemide marked as discontinued after a series of approved labeling and manufacturing supplemental submissions.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Labeling for Discontinued Enalapril/Hydrochlorothiazide ANDA076486
FDA records show that MPP Pharma's ANDA076486 for two oral enalapril maleate/hydrochlorothiazide tablets received multiple labeling approvals, but both products are listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues Duraquin (Quinine Gluconate) – NDA017917
FDA records show Warner Chilcott's Duraquin oral extended‑release tablet (quinine gluconate 330 mg) is discontinued under application NDA017917.
Regulatory Updates
Sep 25, 2026•1 min read
Bell Pharma’s Chlorpheniramine Maleate Tablet (ANDA083062) Listed as Discontinued
Bell Pharma’s oral tablet of chlorpheniramine maleate (4 mg) under ANDA083062 has been marked as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues FOLEX Injectable Methotrexate Products (ANDA087695)
The FDA's ANDA087695 filing for FOLEX injectable methotrexate (25 mg, 50 mg, 100 mg) shows all three products are listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA ANDA088048 Approval for Fluocinolone Acetonide Topical Solution (Discontinued)
The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA078380 Sildenafil Citrate Tablet (20 mg) – Discontinued
The FDA has issued labeling approvals for ANDA078380, a 20 mg sildenafil citrate tablet by Teva Pharmaceuticals, now listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Labeling for Sun Pharm Amlodipine Besylate (ANDA078081)
FDA approved a labeling supplement for Sun Pharm's amlodipine besylate tablets (2.5 mg, 5 mg, 10 mg) under ANDA078081; the products are currently listed as discontinued.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA083784 for Meclizine Hydrochloride 12.5 mg Tablet
The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA078145 for Ketorolac Tromethamine Injectable Products
The FDA has approved ANDA078145 for two injectable ketorolac tromethamine products (15 mg/mL and 30 mg/mL), both listed as discontinued.
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