Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019049
Company: VALEANT BERMUDA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETIN-A TRETINOIN 0.025% 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
09/16/1988 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-23 Manufacturing (CMC)

Label is not available on this site.

01/08/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/06/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/20/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/2002 SUPPL-11 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-10 Manufacturing (CMC)

Label is not available on this site.

07/23/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/10/2002 SUPPL-8 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-7 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-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1990 SUPPL-3 Labeling

Label is not available on this site.

08/28/1990 SUPPL-2 Labeling

Label is not available on this site.

12/01/1989 SUPPL-1 Manufacturing (CMC)-Packaging

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-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

RETIN-A

CREAM;TOPICAL; 0.025%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVITA TRETINOIN 0.025% CREAM;TOPICAL Prescription No AB 020404 MYLAN PHARMS INC
RETIN-A TRETINOIN 0.025% CREAM;TOPICAL Prescription Yes AB 019049 VALEANT BERMUDA
TRETINOIN TRETINOIN 0.025% CREAM;TOPICAL Prescription No AB 075264 PERRIGO PHARMA INTL

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