Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017340
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETIN-A TRETINOIN 0.1% CREAM;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
01/26/1973 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
05/13/2016 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/17/2015 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/08/2013 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/06/2002 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/2002 SUPPL-36 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-35 Manufacturing (CMC)

Label is not available on this site.

07/23/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/10/2002 SUPPL-33 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-32 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-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1990 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1990 SUPPL-28 Labeling

Label is not available on this site.

08/28/1990 SUPPL-27 Labeling

Label is not available on this site.

12/01/1989 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/1989 SUPPL-25 Labeling

Label is not available on this site.

08/26/1986 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/11/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/24/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/30/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/28/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1982 SUPPL-17 Labeling

Label is not available on this site.

12/04/1978 SUPPL-15 Labeling

Label is not available on this site.

01/04/1977 SUPPL-14 Labeling

Label is not available on this site.

06/30/1976 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/27/1974 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1974 SUPPL-9

Label is not available on this site.

04/15/1974 SUPPL-7

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-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

RETIN-A

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.1% CREAM;TOPICAL Prescription Yes AB 017340 VALEANT PHARMS NORTH
TRETINOIN TRETINOIN 0.1% CREAM;TOPICAL Prescription No AB 075213 PERRIGO PHARMA INTL
TRETINOIN TRETINOIN 0.1% CREAM;TOPICAL Prescription No AB 211645 TARO PHARMS

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