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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213601
Company: XIROMED

Products on ANDA 213601

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOCONAZOLE	KETOCONAZOLE	2%	AEROSOL, FOAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213601

KETOCONAZOLE

AEROSOL, FOAM;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	2%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	091550	PADAGIS ISRAEL
KETOCONAZOLE	KETOCONAZOLE	2%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	213601	XIROMED

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