Zydus Pharms gets FDA approvals for selenious acid ANDA and two glyburide/metformin label updates
Zydus Pharms secured a new ANDA approval for injectable selenious acid and two labeling supplement approvals for its glyburide and metformin hydrochloride tablets, all dated June 30, 2026.
Zydus Pharms had three FDA approvals recorded for the week ending June 30, 2026.
- Zydus Pharms received original approval for its ANDA covering selenious acid, an intravenous solution, in three strengths, all approved as of June 30, 2026.1
- Zydus Pharms received approval for a labeling supplement (submission 1) to its ANDA for glyburide and metformin hydrochloride oral tablets, available in three dose combinations, approved as of June 30, 2026.2
- Zydus Pharms received approval for a second labeling supplement (submission 2) to the same glyburide and metformin hydrochloride ANDA, covering the same three tablet strengths, also approved as of June 30, 2026.3
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