FDA Approves ANDA078902 for Paroxetine Hydrochloride Tablets

The U.S. Food and Drug Administration announced approval of Abbreviated New Drug Application (ANDA) number 078902 for paroxetine hydrochloride tablets. The product is listed under the brand name PAROXETINE and is manufactured by Mylan Pharmaceuticals Inc. The approved tablets are oral dosage forms available in four strengths: 10 mg, 20 mg, 30 mg, and 40 mg base equivalent. All are prescription‑only products. The FDA record includes multiple labeling submissions (submission numbers 5, 7, 10, 14, 17, and 22) with the most recent submission dated 23 January 2023, each marked as approved (status “AP”). The product is identified by several NDC codes (0378‑7001‑93, 0378‑7001‑10, 0378‑7002‑93, 0378‑7002‑10, 0378‑7003‑93, 0378‑7003‑10, 0378‑7004‑93, 0378‑7004‑10) and is classified as a human prescription drug.