01 3Aspen Pharmacare Holdings
02 2Dr. Reddy's Laboratories
03 2Taro Pharmaceutical Industries
04 1ARTHUR GRP
05 1Acrotech Biopharma
06 2Actavis Inc
07 1Ajanta Pharma Limited
08 1Almaject
09 2Apotex Inc
10 1BPI Labs
11 1Delcath Systems
12 1ENDO OPERATIONS
13 1Fresenius Kabi USA
14 1GLAND PHARMA LIMITED
15 1Hetero Drugs
16 1Hikma Pharmaceuticals
17 2MARCAN PHARMACEUTICALS INC
18 1Meitheal Pharmaceuticals
19 1Sagent Pharmaceuticals
20 1US WorldMeds
21 2Viatris
01 17INJECTABLE;INJECTION
02 1Injection
03 2KIT
04 1POI
05 1POWDER;INTRA-ARTERIAL
06 2POWDER;INTRAVENOUS
07 4SOLUTION
08 1SOLUTION;INTRAVENOUS
01 5DISCN
02 1Lead Market Dossiers- Approved in US
03 1Originator
04 6Prescription
05 16RX
01 3ALKERAN
02 1Alkeran 50
03 1EVOMELA
04 1HEPZATO
05 1IVRA
06 2MELPHALAN FOR INJECTION
07 17MELPHALAN HYDROCHLORIDE
08 2TARO-MELPHALAN
09 1Blank
01 6Canada
02 1India
03 1South Africa
04 21USA
Regulatory Info : Prescription
Registration Country : Canada
MELPHALAN (MELPHALAN HYDROCHLORIDE)
Brand Name : ALKERAN
Dosage Form : SOLUTION
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 : SOLUTION
Dosage Strength : 10ML/VIAL
Packaging : 10ML
Approval Date :
Application Number : 2087286
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Alkeran 50
Dosage Form : POI
Dosage Strength : 5mg/ml
Packaging : 10X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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 : Prescription
Registration Country : Canada
MELPHALAN (MELPHALAN HYDROCHLORIDE)
Brand Name : TARO-MELPHALAN
Dosage Form : KIT
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date :
Application Number : 2480026
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TARO-MELPHALAN
Dosage Form : KIT
Dosage Strength : 10ML/VIAL
Packaging :
Approval Date :
Application Number : 2480026
Regulatory Info : Prescription
Registration Country : Canada
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 : 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 : 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 : 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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