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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201379
Company: SAGENT PHARMS INC

Products on ANDA 201379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201379Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 201379

MELPHALAN HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206018	ACTAVIS LLC
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204817	ALMAJECT
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211463	ARTHUR GRP
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209197	BPI LABS
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203655	DR REDDYS
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203393	FRESENIUS KABI USA
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209826	GLAND PHARMA LTD
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090303	HIKMA
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210947	INGENUS PHARMS LLC
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212960	MEITHEAL
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090270	MYLAN INSTITUTIONAL
MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201379	SAGENT PHARMS INC

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