Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076498
Company: ZO SKIN HEALTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription AB2 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
09/15/2005 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
03/16/2015 SUPPL-10 Labeling

Label is not available on this site.

03/12/2009 SUPPL-7 Labeling

Label is not available on this site.

12/15/2008 SUPPL-6 Labeling

Label is not available on this site.

TRETINOIN

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENOVA TRETINOIN 0.05% CREAM;TOPICAL Prescription Yes AB2 019963 VALEANT PHARMS NORTH
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription No AB2 076498 ZO SKIN HEALTH

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