Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017522
Company: VALEANT BERMUDA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETIN-A TRETINOIN 0.05% CREAM;TOPICAL Prescription AB1 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
07/19/1974 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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-38 Manufacturing (CMC)

Label is not available on this site.

01/08/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/06/2002 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/2002 SUPPL-26 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-25 Manufacturing (CMC)

Label is not available on this site.

07/23/1998 SUPPL-24 Manufacturing (CMC)

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
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
01/24/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1990 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1990 SUPPL-18 Labeling

Label is not available on this site.

08/28/1990 SUPPL-17 Labeling

Label is not available on this site.

12/01/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/1986 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/23/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/29/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1982 SUPPL-8 Labeling

Label is not available on this site.

04/28/1980 SUPPL-7 Labeling

Label is not available on this site.

12/01/1978 SUPPL-5 Labeling

Label is not available on this site.

04/19/1978 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/04/1977 SUPPL-3 Labeling

Label is not available on this site.

06/29/1976 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/24/1974 SUPPL-1 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-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-23 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

RETIN-A

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.05% CREAM;TOPICAL Prescription Yes AB1 017522 VALEANT BERMUDA
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription No AB1 075265 PERRIGO PHARMA INTL
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription No AB1 211644 TARO PHARMS

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