Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075260
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 0.05% 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
01/25/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-260_Tretinoin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75260ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-260_Tretinoin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-260_Tretinoin_prntlbl.pdf

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