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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206197
Company: FRESENIUS KABI USA

Products on ANDA 206197

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 206197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206197Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206197Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/06/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/06/2021	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Labels for ANDA 206197

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206197Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 206197

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	214683	PIRAMAL CRITICAL
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213106	QILU PHARM HAINAN

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