Actualizaciones regulatorias
27 sept 2026•1 min de lectura
FDA Approves ANDA 078567 for Mylan’s Ciclopirox 8% Topical Solution
The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.
Actualizaciones regulatorias
22 sept 2026•1 min de lectura
FDA Approves Manufacturing Submission for Mylan’s Thioridazine Hydrochloride Tablet (ANDA088332)
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.
Actualizaciones regulatorias
22 sept 2026•1 min de lectura
FDA Approves Mylan Sumatriptan Succinate Tablets (ANDA 077744)
The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.
Actualizaciones regulatorias
17 sept 2026•1 min de lectura
FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)
The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.
Actualizaciones regulatorias
15 sept 2026•1 min de lectura
FDA Lists ANDA083706 for Mylan Propantheline Bromide 15 mg Tablet
FDA records an ANDA (ANDA083706) for Mylan's oral propantheline bromide 15 mg tablet, currently marked as discontinued.
Actualizaciones regulatorias
12 sept 2026•1 min de lectura
FDA Approves ANDA078902 for Paroxetine Hydrochloride Tablets
The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
FDA Lists Two Discontinued Fluconazole Injection Products Under ANDA 076889
FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
FDA Approves Mylan Nisoldipine Extended‑Release Tablets (ANDA 079051) – Discontinued Products
The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
Mylan's Chlordiazepoxide Hydrochloride Oral Capsule (ANDA 084887) Discontinued
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.
Actualizaciones regulatorias
8 sept 2026•1 min de lectura
FDA ANDA084259 for Methocarbamol 500 mg Oral Tablet (Mylan) – Discontinued
The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Approves ANDA078641 for Injectable Famotidine (Mylan)
FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Approves Mylan Fentanyl Transdermal Patches (ANDA076258)
The FDA has approved Mylan Pharmaceuticals' fentanyl transdermal extended‑release patches (ANDA076258) in multiple dosage strengths for prescription use.