Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076367
Company: TARO PHARM INDS

Products on ANDA 076367

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076367

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076367

AMCINONIDE

OINTMENT;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%	OINTMENT;TOPICAL	Prescription	No	AB	076096	GENUS
AMCINONIDE	AMCINONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	076367	TARO PHARM INDS