Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020475
Company: VALEANT INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETIN-A MICRO TRETINOIN 0.1% GEL;TOPICAL Prescription AB Yes Yes
RETIN-A MICRO TRETINOIN 0.04% GEL;TOPICAL Prescription AB Yes Yes
RETIN-A-MICRO TRETINOIN 0.08% GEL;TOPICAL Prescription None Yes Yes
RETIN-A-MICRO TRETINOIN 0.06% GEL;TOPICAL Prescription None 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
02/07/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020475ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/29/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/28/2014 SUPPL-21 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020475Org1s021.pdf
01/08/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/26/2009 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

05/10/2002 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20475s008ltr.pdf
03/20/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/2000 SUPPL-6 Labeling

Label is not available on this site.

04/05/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/23/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/13/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/28/2014 SUPPL-21 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf
05/10/2002 SUPPL-8 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf

RETIN-A MICRO

GEL;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A MICRO TRETINOIN 0.1% GEL;TOPICAL Prescription Yes AB 020475 VALEANT INTL
TRETINOIN TRETINOIN 0.1% GEL;TOPICAL Prescription No AB 202026 MYLAN PHARMS INC

GEL;TOPICAL; 0.04%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A MICRO TRETINOIN 0.04% GEL;TOPICAL Prescription Yes AB 020475 VALEANT INTL
TRETINOIN TRETINOIN 0.04% GEL;TOPICAL Prescription No AB 202567 MYLAN PHARMS INC

RETIN-A-MICRO

There are no Therapeutic Equivalents.

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