U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212178
Company: ZYDUS LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFINACONAZOLE EFINACONAZOLE 10% SOLUTION;TOPICAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/15/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/14/2024 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Back to Top