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01 2Aspen Pharmacare Holdings
02 2Dr. Reddy's Laboratories
03 1ARTHUR GRP
04 1Acrotech Biopharma
05 2Actavis Inc
06 1Almaject
07 2Apotex Inc
08 1Avet Pharmaceuticals
09 1BPI Labs
10 1Delcath Systems
11 1Fresenius Kabi USA
12 1GLAND PHARMA LIMITED
13 1Hetero Drugs
14 2Hikma Pharmaceuticals
15 2MARCAN PHARMACEUTICALS INC
16 1Meitheal Pharmaceuticals
17 1Novast Laboratories
18 1PH HEALTH
19 1Sagent Pharmaceuticals
20 1Tarbis Farma Sl
21 2Taro Pharmaceutical Industries
22 1US WorldMeds
23 2Viatris
24 1Zentiva
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01 18INJECTABLE;INJECTION
02 1Injection
03 4KIT
04 1POWDER;INTRA-ARTERIAL
05 2POWDER;INTRAVENOUS
06 3Powder And Solvent For Injection And Infusion Solution
07 2SOLUTION
08 1SOLUTION;INTRAVENOUS
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01 3Authorized
02 5DISCN
03 1Lead Market Dossiers- Approved in US
04 6Prescription
05 17RX
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01 3ALKERAN
02 1EVOMELA
03 1HEPZATO
04 1IVRA
05 2MELPHALAN FOR INJECTION
06 18MELPHALAN HYDROCHLORIDE
07 1Melfalan Hikma
08 1Melfalan Tarbis
09 1Melfalan Zentiva
10 2TARO-MELPHALAN
11 1Blank
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01 6Canada
02 1India
03 3Spain
04 22USA
Regulatory Info : Prescription
Registration Country : Canada
MELPHALAN (MELPHALAN HYDROCHLORIDE)
Brand Name : ALKERAN
Dosage Form : KIT
Dosage Strength : 50MG/VIAL
Packaging : 10ML
Approval Date :
Application Number : 2087286
Regulatory Info : Prescription
Registration Country : Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2017-12-08
Application Number : 203655
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ALKERAN
Dosage Form : KIT
Dosage Strength : 10ML/VIAL
Packaging : 10ML
Approval Date :
Application Number : 2087286
Regulatory Info : Prescription
Registration Country : Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Approved in US
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Approved in US
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : EVOMELA
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2016-03-10
Application Number : 207155
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2016-12-19
Application Number : 206018
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2020-03-06
Application Number : 209323
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2019-05-17
Application Number : 204817
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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**
Packaging :
Approval Date : 1992-11-18
Application Number : 20207
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2024-10-29
Application Number : 206523
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2020-05-08
Application Number : 209197
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HEPZATO
Dosage Form : POWDER;INTRA-ARTERIAL
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2023-08-14
Application Number : 201848
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2017-12-22
Application Number : 203393
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2019-05-28
Application Number : 209826
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2010-10-28
Application Number : 90303
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2017-02-28
Application Number : 201379
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2019-05-03
Application Number : 207032
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2009-06-09
Application Number : 90270
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2009-10-27
Application Number : 90299
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MELPHALAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2016-08-22
Application Number : 204773
Regulatory Info : DISCN
Registration Country : USA
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