Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076065
Company: GENUS LIFESCIENCES

Products on ANDA 076065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMCINONIDE	AMCINONIDE	0.1%	CREAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076065

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076065

AMCINONIDE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMCINONIDE	AMCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	076065	GENUS LIFESCIENCES
AMCINONIDE	AMCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	076229	TARO PHARM INDS