Drugs@FDA: FDA-Approved Drugs
Company: VALEANT INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.05% | SOLUTION;TOPICAL | Discontinued | None | Yes | No |
RETIN-A | TRETINOIN | 0.05% | SWAB;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 |
---|---|---|---|---|---|---|---|
10/20/1971 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/10/2002 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
01/25/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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07/23/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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06/10/2002 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
06/10/2002 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
01/24/1992 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/28/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
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07/22/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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06/06/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/13/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
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04/28/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
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10/24/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/04/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
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01/04/1977 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/20/1974 | SUPPL-9 | 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 |
---|---|---|---|---|---|
06/10/2002 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
06/10/2002 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
06/10/2002 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf |