Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211769
Company: GLENMARK PHARMS LTD

Products on ANDA 211769

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIMECROLIMUS	PIMECROLIMUS	1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211769

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211769

PIMECROLIMUS

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELIDEL	PIMECROLIMUS	1%	CREAM;TOPICAL	Prescription	Yes	AB	021302	BAUSCH
PIMECROLIMUS	PIMECROLIMUS	1%	CREAM;TOPICAL	Prescription	No	AB	209345	ACTAVIS LABS UT INC
PIMECROLIMUS	PIMECROLIMUS	1%	CREAM;TOPICAL	Prescription	No	AB	211769	GLENMARK PHARMS LTD