Regulatorische Updates

The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.

The FDA has approved Mylan’s supplemental application (ANDA088332) for a 10 mg oral tablet of thioridazine hydrochloride, though the product is listed as discontinued.

The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.

The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.

FDA records an ANDA (ANDA083706) for Mylan's oral propantheline bromide 15 mg tablet, currently marked as discontinued.

The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.

FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.

The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.

Mylan's oral capsule product containing 25 mg chlordiazepoxide hydrochloride (product 001) is listed as discontinued. The ANDA includes four manufacturing (CMC) submissions approved on June 10 1981.

The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.

FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.

The FDA has approved Mylan Pharmaceuticals' fentanyl transdermal extended‑release patches (ANDA076258) in multiple dosage strengths for prescription use.