Zydus Pharms gets two ANDA actions: isotretinoin label supplement, ascorbic acid injection approval
Zydus Pharms received FDA approval of an original ANDA for intravenous ascorbic acid and a labeling supplement for its isotretinoin capsules, both dated late August 2026.
Zydus Pharms had two ANDA actions approved by the FDA in the week ending August 21, 2026.
- A labeling supplement (submission number 8) for isotretinoin capsules, covering 10MG, 20MG, 30MG, and 40MG oral strengths under ANDA211568, was approved with a status date of 2026-08-21.1
- An original ANDA (ANDA220873) for intravenous ascorbic acid solution, in three strengths including 2,500MG/5ML, 5,000MG/10ML, and 25,000MG/50ML, was approved with a status date of 2026-08-20.2
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