Drugs@FDA: FDA Approved Drug Products

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 PERRIGO PHARMA INTL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English