The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA212645, covering paroxetine extended‑release tablets. The approval applies to products manufactured by Cadila Pharmaceuticals Limited (listed as CADILA PHARMS LTD) and Modavar Pharmaceuticals LLC.
Three dosage strengths are authorized: 12.5 mg, 25 mg, and 37.5 mg base equivalents of paroxetine hydrochloride, all formulated as oral extended‑release tablets. Each product is designated as prescription‑only and is not a reference drug.
The FDA’s submission records show labeling approvals for multiple supplemental submissions (numbers 1, 2, and 4) dated August 29 2024, and an original submission approved on August 27 2021. All submissions were reviewed under standard priority.
The approved products are identified by various NDC codes, including 72241‑029‑22, 72241‑030‑10, and 71209‑094‑01, among others, reflecting the different strengths and packaging configurations.
Regulatory UpdatesSep 18, 2026•3 min read
FDA Approves ANDA212645 for Paroxetine Extended‑Release Tablets
The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.
Compiled by the Pharmacountry team · Source: FDA.gov
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