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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 212960


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NDA 212960 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Arthur Grp, Avet Lifesciences, Bpi Labs, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Sagent Pharms Inc, and Uswm, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the MELPHALAN HYDROCHLORIDE profile page.

The generic ingredient in MELPHALAN HYDROCHLORIDE is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 212960
Tradename:MELPHALAN HYDROCHLORIDE
Applicant:Meitheal
Ingredient:melphalan hydrochloride
Patents:0
Suppliers and Packaging for NDA: 212960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 212960 ANDA Meitheal Pharmaceuticals Inc. 71288-132 71288-132-90 1 KIT in 1 CARTON (71288-132-90) * 15 mL in 1 VIAL, SINGLE-DOSE (71288-130-15) * 10 mL in 1 VIAL, SINGLE-USE (71288-131-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:May 28, 2021TE:APRLD:No

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