Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020404
Company: MYLAN PHARMS INC

Products on NDA 020404

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/1997	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/30/2001	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/31/2000	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/15/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for NDA 020404

AVITA

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	BAUSCH
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	075264	PADAGIS US
TRETINOIN	TRETINOIN	0.025%	CREAM;TOPICAL	Prescription	No	AB	215713	TARO