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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200744
Company: FOUGERA PHARMS INC

Products on ANDA 200744

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	AB	No	No
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200744

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2014	ORIG-1	Approval	Not Applicable		Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200744Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/200744Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/29/2015	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 200744

TACROLIMUS

OINTMENT;TOPICAL; 0.03%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROTOPIC	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	Yes	AB	050777	LEO PHARMA AS
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	No	AB	211688	ACCORD HLTHCARE
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	No	AB	200744	FOUGERA PHARMS INC
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	No	AB	210393	GLENMARK PHARMS LTD

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

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