Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209345
Company: ACTAVIS LABS UT INC

Products on ANDA 209345

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 209345

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209345Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 209345

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