Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 076886 for Fosphenytoin Sodium Injection (DR REDDYS)
The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Ranbaxy Gabapentin Tablet ANDA076605 (600 mg & 800 mg)
The FDA approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA217961 for CARBIDOPA 25mg Oral Tablet
The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Artesunate Injection (NDA 213036) – Orphan Drug Designation
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.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Grants ANDA079044 Approval for Nicotine Polacrilex Chewing Gum (OTC)
The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves ANDA 084872 for Meclizine Hydrochloride 25 mg Tablet (BUNDY)
The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 080630 for Cortisone Acetate 25 mg Tablet
The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA088010 for Chlordiazepoxide Hydrochloride Capsule
FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Irbesartan/Hydrochlorothiazide Combination Tablets (ANDA 077446)
The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 077139 for Teva’s Intravenous Carboplatin Injectable Products
The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.
Regulatory Updates
Sep 21, 2026•1 min read
MFDS eases safety data burden for medical gases and expands orphan‑drug ingredient specs
MFDS announced partial amendments to drug approval regulations, reducing documentation for medical high‑pressure gases and widening multiple‑specification allowances for orphan‑drug active ingredients.