Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Fresenius Kabi’s OCTREOTIDE Acetate Injectable (ANDA 077457)
The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.
Regulatory Updates
Sep 3, 2026•1 min read
Woodward’s Milrinone Lactate Injection Products Discontinued – ANDA077151
FDA records show two Woodward Milrinone Lactate injectable products are listed as discontinued under ANDA077151.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA084712 for Bethanechol Chloride Tablet (10 mg) – Lannett
The FDA has approved ANDA084712 for Bethanechol Chloride 10 mg tablets, marketed by Lannett, now listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Actavis Labs Metoprolol Succinate Extended‑Release Tablets (ANDA 076862)
Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA 076576 for Sotalol Hydrochloride Tablets by Sun Pharm Industries
The FDA approved application ANDA076576 for oral Sotalol Hydrochloride tablets (80 mg, 120 mg, 160 mg) from Sun Pharm Industries; all listed products are marked discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA083606 for Butabarital Sodium Oral Tablet
The FDA approved ANDA083606 for an oral tablet of butabarital sodium (16.2 mg) submitted by Solvay; the product is listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Cipla Cetirizine Allergy Tablets (ANDA077318)
FDA has approved Cipla Ltd.'s ANDA077318 for two oral cetirizine hydrochloride allergy tablets (5 mg and 10 mg), both listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Lists ANDA076458 for Fluoxetine Hydrochloride Oral Solution (Discontinued)
The FDA database shows ANDA076458 for fluoxetine hydrochloride oral solution, marketed under the brand Fluoxetine, with a discontinued status and multiple labeling submissions.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA078511 for Midazolam Hydrochloride Injection
FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
CARACO Receives Tentative FDA Approval for Escitalopram (ANDA078219)
CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.
Regulatory Updates
Sep 3, 2026•1 min read
Cipla Efavirenz 600mg Tablet Gets FDA Tentative Approval (ANDA 077916)
Cipla Limited’s generic efavirenz 600 mg tablet has been granted tentative approval by the FDA under ANDA 077916.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA209610 for Clindamycin Phosphate and Benzoyl Peroxide Gel
The FDA has approved ANDA209610 for a prescription topical gel combining clindamycin phosphate (EQ 1.2% base) and benzoyl peroxide (3.75%). The product is marketed by Padagis Israel Pharmaceuticals Ltd.