Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075260
Company: WOCKHARDT
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 |