Actualités réglementaires
27 sept. 2026•1 min de lecture
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.
Actualités réglementaires
22 sept. 2026•1 min de lecture
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.
Actualités réglementaires
22 sept. 2026•1 min de lecture
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.
Actualités réglementaires
17 sept. 2026•1 min de lecture
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.
Actualités réglementaires
15 sept. 2026•1 min de lecture
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.
Actualités réglementaires
12 sept. 2026•1 min de lecture
FDA Approves ANDA078902 for Paroxetine Hydrochloride Tablets
The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
8 sept. 2026•1 min de lecture
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.
Actualités réglementaires
3 sept. 2026•1 min de lecture
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.
Actualités réglementaires
30 août 2026•1 min de lecture
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.