Orange Book product · Generic (ANDA)
MELPHALAN HYDROCHLORIDE
MELPHALAN HYDROCHLORIDE
At a glance
Mar 06, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 06, 2020
6 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MELPHALAN HYDROCHLORIDE
Strength
EQ 50MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 209323
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MELPHALAN HYDROCHLORIDE
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ANDA 206523 · AVET LIFESCIENCES
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ANDA 215024 · HETERO LABS
- 2021MELPHALAN HYDROCHLORIDEGeneric (ANDA)
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ANDA 209197 · BPI LABS
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ANDA 210947 · INGENUS PHARMS LLC
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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.
