U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017579
Company: VALEANT INTL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETIN-A TRETINOIN 0.025% GEL;TOPICAL Prescription AB Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/18/1975 ORIG-1 Approval Type 3 - New Dosage Form 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
05/14/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
03/20/2001 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/10/2002 SUPPL-23 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-22 Manufacturing (CMC)

Label is not available on this site.
07/23/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
06/10/2002 SUPPL-20 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-18 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
01/31/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
07/03/1990 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
08/28/1990 SUPPL-14 Labeling

Label is not available on this site.
08/28/1990 SUPPL-13 Labeling

Label is not available on this site.
12/01/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/11/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
07/23/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
11/30/1982 SUPPL-8 Labeling

Label is not available on this site.
07/29/1981 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
04/28/1980 SUPPL-5 Labeling

Label is not available on this site.
10/23/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
12/01/1978 SUPPL-3 Labeling

Label is not available on this site.
06/14/1977 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/04/1977 SUPPL-1 Labeling

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-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

RETIN-A

GEL;TOPICAL; 0.025%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.025% GEL;TOPICAL Prescription Yes AB 017579 VALEANT INTL
TRETINOIN TRETINOIN 0.025% GEL;TOPICAL Prescription No AB 075529 PADAGIS US
Back to Top