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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075264
Company: PADAGIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 0.025% CREAM;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/24/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75264_Tretinoin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75264_Tretinoin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2007 SUPPL-26 Labeling

Label is not available on this site.

02/21/2007 SUPPL-24 Labeling

Label is not available on this site.

10/24/2001 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/24/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

02/29/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1999 SUPPL-3 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
12/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75264_Tretinoin_prntlbl.pdf

TRETINOIN

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 PADAGIS US
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