Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210947
Company: INGENUS PHARMS LLC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/18/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

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
ALKERAN MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020207 APOTEX
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 209197 BPI LABS LLC
MELPHALAN HYDROCHLORIDE MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203655 DR REDDYS LABS LTD
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 210947 INGENUS PHARMS LLC
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
MELPHALAN HYDROCHLORIDE MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090303 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English