規制動向

The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.

The FDA’s ANDA 077179 approval covers oral capsule products of amlodipine besylate combined with benazepril hydrochloride, all listed as discontinued, with labeling submissions approved in 2011 and 2016.

The FDA has issued labeling approvals for ANDA078380, a 20 mg sildenafil citrate tablet by Teva Pharmaceuticals, now listed as discontinued.

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.

Alvogen’s discontinued topical gel CICLOPIROX (0.77%) received FDA labeling submissions in 2013, with earlier filings dating back to 1997.

The FDA granted approval for artesunate 110 mg/vial for intravenous use under NDA 213036, an orphan-designated new molecular entity, with labeling updates through 2025.

The FDA has approved ANDA078145 for two injectable ketorolac tromethamine products (15 mg/mL and 30 mg/mL), both listed as discontinued.

FDA records show multiple manufacturing and labeling approvals for Glycine 1.5% irrigation solution (NDA 017633); the product is now discontinued.

The FDA records show that three discontinued oral delayed‑release tablet products of Divalproex Sodium (125 mg, 250 mg, 500 mg) received approved labeling supplemental submissions.

The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.

The FDA has approved ANDA076568 for Nicotine Polacrilex chewing gum, an over‑the‑counter nicotine replacement product available in 4 mg and 2 mg strengths.

FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.