Zydus Pharms gets two FDA label supplement approvals for dexmedetomidine injection
FDA approved two labeling supplements for Zydus Pharms' dexmedetomidine hydrochloride injection under ANDA206798, both dated July 8, 2026.
Zydus Pharms recorded two approved labeling changes to its generic dexmedetomidine hydrochloride injectable this week, both tied to the same underlying application.
- FDA approved a labeling supplement (submission number 2) for Zydus Pharms' dexmedetomidine hydrochloride injection, 200mcg base/2mL, under ANDA206798, with a submission status date of 2026-07-08.1
- FDA also approved a separate labeling supplement (submission number 3) for the same dexmedetomidine hydrochloride injection product under ANDA206798, also dated 2026-07-08.2
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.