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Sep 3, 2026Regulatory decision

Cadila Pharms wins ANDA labeling supplement approval for acyclovir tablets

FDA approved a labeling supplement for Cadila Pharms Ltd's acyclovir tablet ANDA on September 3, 2026.

This week's filing activity for Cadila Pharms Ltd centers on a single regulatory update.

  • Acyclovir, oral tablet, ANDA202168: FDA approved supplement number 4, a labeling submission, with a submission status date of 2026-09-031. The application covers 800MG and 400MG oral tablet strengths1, and the submission carried standard review priority.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.