An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209826
Company: GLAND PHARMA LTD

Products on ANDA 209826

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 209826

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209826

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

Top