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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212957
Company: NAVINTA LLC

Products on ANDA 212957

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212957

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212957

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS; EQ 150MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EMEND	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	022023	MERCK AND CO INC
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214616	ASPIRO
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211860	BAXTER HLTHCARE CORP
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212309	BE PHARMS
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212143	CHIA TAI TIANQING
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211160	DR REDDYS
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	210625	EUGIA PHARMA
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206197	FRESENIUS KABI USA
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	210689	LUPIN LTD
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	209965	MSN
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	204015	MYLAN LABS LTD
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212957	NAVINTA LLC
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214683	PIRAMAL CRITICAL
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213106	QILU PHARM HAINAN

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