Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075529
Company: PADAGIS US

Products on ANDA 075529

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075529

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75529ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75529_Tretinoin.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/20/2007	SUPPL-10	Labeling		Label is not available on this site.
02/21/2007	SUPPL-8	Labeling		Label is not available on this site.
07/11/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/13/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075529

TRETINOIN

GEL;TOPICAL; 0.025%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETIN-A	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	Yes	AB	017579	VALEANT INTL
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	No	AB	218245	AUROBINDO PHARMA LTD
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	No	AB	217587	ENCUBE
TRETINOIN	TRETINOIN	0.025%	GEL;TOPICAL	Prescription	No	AB	075529	PADAGIS US