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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204015
Company: MYLAN LABS LTD

Products on ANDA 204015

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER;INTRAVENOUS	Discontinued	None	No	No
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2019	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204015Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/17/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204015

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	204025	ACCORD HLTHCARE
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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