Glenmark posts two ANDA labeling supplement approvals for metformin, riluzole
FDA approved labeling supplements for Glenmark Pharms' generic metformin hydrochloride and riluzole applications, both dated August 11, 2026.
Glenmark Pharms Ltd had two labeling supplements approved by the FDA during the week, covering its metformin hydrochloride and riluzole ANDAs.
- Metformin Hydrochloride, an oral tablet available in 1GM, 500MG, and 850MG strengths under ANDA078170, received approval for its 22nd labeling supplement, with a submission status date of 2026-08-11.1
- Riluzole, a 50MG oral tablet under ANDA091394, received approval for its 8th labeling supplement, also dated 2026-08-11.2
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