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Approved Drug Products containing Melphalan Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2017-12-08

Application Number : 203655

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2019-05-17

Application Number : 204817

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : ALKERAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1992-11-18

Application Number : 20207

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : HEPZATO

Dosage Form : POWDER;INTRA-ARTERIAL

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2023-08-14

Application Number : 201848

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2017-12-22

Application Number : 203393

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2010-10-28

Application Number : 90303

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2017-02-28

Application Number : 201379

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2009-06-09

Application Number : 90270

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2009-10-27

Application Number : 90299

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

ENDO OPERATIONS

Country
Discovery on Target
Not Confirmed
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ENDO OPERATIONS

Country
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Discovery on Target
Not Confirmed

MELPHALAN HYDROCHLORIDE

Brand Name : MELPHALAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2016-08-22

Application Number : 204773

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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