The U.S. Food and Drug Administration has granted approval for Abbreviated New Drug Application (ANDA) 211623 covering generic carbamazepine extended‑release tablets.
The approved product, submitted by Unique Pharm and manufactured by Rising Pharma Holdings, Inc., is available in oral tablet form with strengths of 100 mg, 200 mg, and 400 mg. The tablets are prescription‑only and carry NDC codes 16571‑680‑01, 16571‑681‑01, and 16571‑682‑01.
The original submission (type ORIG, number 1) received approval on 24 April 2020. A supplemental labeling amendment (type SUPPL, number 4) was approved on 29 January 2024.
규제 업데이트2026년 9월 24일•1분 읽기
FDA Approves ANDA211623 for Generic Carbamazepine Extended‑Release Tablets
The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.
PharmaCountry 팀이 정리했습니다 · 출처: FDA.gov
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