Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203655
Company: DR REDDYS LABS LTD
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
12/08/2017 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203655Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203655Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203655Orig1s000lbl.pdf

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 ALVOGEN
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

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