Regulatory Updates
Sep 11, 2026•1 min read
FDA Grants ANDA206918 Approval for Fondaparinux Sodium Injection
The FDA approved ANDA206918 for Fondaparinux Sodium subcutaneous solutions, manufactured by Eugia Pharma, with multiple dosage strengths and NDC codes.
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Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Hikma Deferoxamine Mesylate Injectable (ANDA078086)
FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Risperidone Tablet ANDA077784 Submitted by Ratipharm
FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA077183 for Amlodipine Besylate and Benazepril Hydrochloride
The FDA has granted approval for ANDA077183, a prescription oral capsule combining amlodipine besylate and benazepril hydrochloride, manufactured by Dr. Reddy's Laboratories.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Chartwell RX Levofloxacin Oral Tablets (ANDA 076890)
The FDA has granted approval for Chartwell RX’s levofloxacin tablets in 250 mg, 500 mg and 750 mg oral strengths under ANDA 076890.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA076609 for Propoxyphene Napyslate/Acetaminophen Tablet
The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Sun Pharma Epoprostenol Injection (ANDA210473)
The FDA has approved Sun Pharmaceutical's epoprostenol injectable (ANDA210473), covering 0.5 mg and 1.5 mg vial strengths for intravenous use.
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Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)
The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA209102 for Generic Baclofen Tablets
The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA208756 for Dexmethylphenidate Tablets (Rhodes Pharm)
The FDA has approved application ANDA208756 submitted by Rhodes Pharm for oral dexmethylphenidate hydrochloride tablets in 2.5 mg, 5 mg and 10 mg strengths, though the products are listed as discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA207613 for Midodrine Hydrochloride Tablets
FDA has approved ANDA207613, authorizing oral Midodrine Hydrochloride prescription tablets in 2.5 mg, 5 mg, and 10 mg strengths from Umasuto and Rising Pharma.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves LEUCOVORIN CALCIUM (ANDA207241)
The FDA has granted approval for LEUCOVORIN CALCIUM (application ANDA207241) manufactured by Fresenius Kabi USA for prescription use.