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MELPHALAN HYDROCHLORIDE

ANDA

MELPHALAN HYDROCHLORIDE | A209323 | ACTAVIS LLC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CyDex Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. et al 1:2017cv01832 3 patentsANDA 209323Melphalan HCl	D. Del.	2017-12-20	Terminated 2019-11-06	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain9 active DMFs2 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAMELPHALAN HYDROCHLORIDE

DMF 208832007

EMCURE PHARMACEUTICALS LTDMELPHALAN HYDROCHLORIDE

DMF 250402011

FARMABIOS SPAMELPHALAN HYDROCHLORIDE

DMF 257912012

NERPHARMA SRLMELPHALAN HYDROCHLORIDE DRUG SUBSTANCE

DMF 273062013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMELPHALAN HYDROCHLORIDE

DMF 274852013

SHILPA PHARMA LIFESCIENCES LTDMELPHALAN HYDROCHLORIDE (MPH)

DMF 289302015

HETERO LABS LTDMELPHALAN HYDROCHLORIDE

DMF 295372015

NAVINTA LLCMELPHALAN HYDROCHLORIDE

DMF 297662015

APITORIA PHARMA PRIVATE LTDMELPHALAN HYDROCHLORIDE

DMF 371792022

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveMELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE)

DMF 236672010

GRANULES INDIA LTDInactiveMELPHALAN HYDROCHLORIDE

DMF 360962021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 14, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Mar 6, 2020

No patent or exclusivity listings for this strength.