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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214811
Company: AMNEAL

Products on ANDA 214811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214811

MUPIROCIN

CREAM;TOPICAL; EQ 2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	214811	AMNEAL
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	213076	ENCUBE
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	201587	GLENMARK PHARMS INC
MUPIROCIN	MUPIROCIN CALCIUM	EQ 2% BASE	CREAM;TOPICAL	Prescription	No	AB	207116	TARO

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