Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091308
Company: APOTEX INC

Products on ANDA 091308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091308

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2012	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091308

IMIQUIMOD

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	091308	APOTEX INC
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	078548	FOUGERA PHARMS
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	201994	GLENMARK PHARMS INC
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	078837	PADAGIS ISRAEL
IMIQUIMOD	IMIQUIMOD	5%	CREAM;TOPICAL	Prescription	No	AB	200173	TARO