Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075589
Company: PADAGIS US

Products on ANDA 075589

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.01%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075589

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.

Therapeutic Equivalents for ANDA 075589

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	BAUSCH
TRETINOIN	TRETINOIN	0.01%	GEL;TOPICAL	Prescription	No	AB	218246	AUROBINDO PHARMA LTD
TRETINOIN	TRETINOIN	0.01%	GEL;TOPICAL	Prescription	No	AB	217588	ENCUBE
TRETINOIN	TRETINOIN	0.01%	GEL;TOPICAL	Prescription	No	AB	075589	PADAGIS US