Regulatory UpdatesSep 25, 2026•1 min read

FDA Approves Glenmark’s Carvedilol Generic Tablets (ANDA078251)

By the PharmaCountry team

The FDA has granted labeling approval for Glenmark Pharmaceuticals’ generic carvedilol tablets (ANDA078251), available in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg oral dosage forms.

The U.S. Food and Drug Administration has issued a labeling approval (status "AP") for the generic drug application ANDA078251 submitted by Glenmark Pharmaceuticals Inc., USA. The approved product is carvedilol, an oral tablet classified as a prescription drug. Four tablet strengths are listed: 3.125 mg (product number 001), 6.25 mg (002), 12.5 mg (003) and 25 mg (004). The associated NDC codes span 68462‑162‑01 to 68462‑165‑10. Labeling submissions for this ANDA have been approved on multiple dates, most recently on 2023‑11‑01 (submission number 19). Earlier approvals were recorded on 2007‑07‑13, 2014‑09‑26 and 2013‑05‑07.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#carvedilol #generic drug #FDA approval #Glenmark #Cardiovascular #Oral Tablet