Regulatory UpdatesSep 8, 2026•1 min read

FDA Approves Watson Labs Ciprofloxacin Ophthalmic Solution (ANDA 076673)

By the PharmaCountry team

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.

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered 076673 for a ciprofloxacin hydrochloride ophthalmic solution. The product, marketed by Watson Labs Inc., is a prescription eye drop (solution/drops) intended for ophthalmic use. The original submission (submission type ORIG, number 1) received approval on January 21, 2005. A supplemental labeling submission (type SUPPL, number 2) was subsequently approved on April 20, 2007, updating the product’s labeling information. Key product details include: - Brand name: Ciprofloxacin Hydrochloride - Route: Ophthalmic - Dosage form: Solution/Drops - Strength: Equivalent to 0.3% base - Marketing status: Prescription - Sponsor: Watson Labs Inc.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Ciprofloxacin #ophthalmic #ANDA #FDA approval #prescription drug #Watson Labs