Orange Book product · Generic (ANDA)
MELPHALAN HYDROCHLORIDE
MELPHALAN HYDROCHLORIDE
At a glance
Oct 29, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
MELPHALAN HYDROCHLORIDE
Strength
EQ 50MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 206523
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MELPHALAN HYDROCHLORIDE
- 2023IVRABrand (NDA)
NDA 217110 · APOTEX
- 2023HEPZATOBrand (NDA)
NDA 201848 · DELCATH SYSTEMS INC
- 2016EVOMELABrand (NDA)
NDA 207155 · ACROTECH BIOPHARMA
- 1992ALKERANBrand (NDA)
NDA 020207 · APOTEX
- 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.
