Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves HIKMA Ciprofloxacin Injection (ANDA078431)
FDA granted labeling approval for HIKMA Farmaceutica's ciprofloxacin 400 mg/200 mL injection under ANDA078431, with multiple supplemental approvals since 2009.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA078598 for Ciprofloxacin Hydrochloride Ophthalmic Solution
The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA approves Bedford ciprofloxacin injection ANDA078114
FDA issued an approval letter for Bedford's ANDA078114 covering ciprofloxacin injection products (200 mg/100 mL and 400 mg/200 mL), both listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Watson Labs Ciprofloxacin Ophthalmic Solution (ANDA 076673)
FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 076484 for Ciprofloxacin Injectable Products by Fresenius Kabi USA
The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Grants ANDA Approval for Ciprofloxacin Hydrochloride Tablets (ANDA 076593)
The FDA approved generic ciprofloxacin hydrochloride tablets (250 mg, 500 mg, 750 mg) under ANDA 076593, sponsored by Aiping Pharm and manufactured by Westminster Pharmaceuticals.