FDA Approves Zydus Generic Galantamine Hydrobromide Tablets (ANDA078898)

The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA078898 submitted by Zydus Pharm USA Inc. The approval covers three oral tablet products containing galantamine hydrobromide as the active ingredient at equivalent strengths of 4 mg, 8 mg, and 12 mg base. All three products are designated as prescription‑only, oral tablets (te_code AB) and are not reference drugs. The sponsor, Zydus Pharm USA Inc., received standard review priority for the submissions. Multiple labeling supplements (submission numbers 1, 2, 5, 6, 7, 9) were approved on dates ranging from 2012‑10‑12 to 2020‑10‑02, confirming the final labeling for each strength. The original ANDA (submission type ORIG, submission number 1) was approved on 17 February 2011, establishing the generic pathway for galantamine hydrobromide tablets in the United States market.