Orange Book product · Brand (NDA)
ALKERAN
MELPHALAN HYDROCHLORIDE
At a glance
Nov 18, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 18, 1992
34 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MELPHALAN HYDROCHLORIDE
Strength
EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020207
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023IVRABrand (NDA)
NDA 217110 · APOTEX
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NDA 201848 · DELCATH SYSTEMS INC
- 2016EVOMELABrand (NDA)
NDA 207155 · ACROTECH BIOPHARMA
- 2024MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 206523 · AVET LIFESCIENCES
- 2024MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 215024 · HETERO LABS
- 2021MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 212960 · MEITHEAL
- 2020MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 209197 · BPI LABS
- 2020MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 209323 · ACTAVIS LLC
- 2020MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 210947 · INGENUS PHARMS LLC
- 2019MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 211463 · ARTHUR GRP
- 2019MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 209826 · GLAND
- 2019MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 204817 · ALMAJECT
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
