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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212443
Company: ENCUBE

Products on ANDA 212443

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212443

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212443

KETOCONAZOLE

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	212443	ENCUBE
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	076294	FOUGERA PHARMS
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075581	TEVA
KETOZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075638	SUN PHARMA CANADA

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