Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016921
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.

07/23/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

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.

08/28/1990 SUPPL-19 Labeling

Label is not available on this site.

07/22/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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.

12/13/1982 SUPPL-14 Labeling

Label is not available on this site.

04/28/1980 SUPPL-13 Labeling

Label is not available on this site.

10/24/1979 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1978 SUPPL-11 Labeling

Label is not available on this site.

01/04/1977 SUPPL-10 Labeling

Label is not available on this site.

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

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