Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212387
Company: ENCUBE

Products on ANDA 212387

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212387

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212387

TACROLIMUS

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROTOPIC	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	Yes	AB	050777	LEO PHARMA AS
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	211688	ACCORD HLTHCARE
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	212387	ENCUBE
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	200744	FOUGERA PHARMS INC
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	210393	GLENMARK PHARMS LTD