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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075589
Company: PADAGIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 0.01% GEL;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
06/11/2002 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2007 SUPPL-6 Labeling

Label is not available on this site.

02/21/2007 SUPPL-4 Labeling

Label is not available on this site.

TRETINOIN

GEL;TOPICAL; 0.01%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.01% GEL;TOPICAL Prescription Yes AB 017955 VALEANT INTL
TRETINOIN TRETINOIN 0.01% GEL;TOPICAL Prescription No AB 075589 PADAGIS US
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