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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 213460

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NDA 213460 describes CARMUSTINE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Dr Reddys, Hengrui Pharma, Ingenus Pharms Llc, Meitheal, MSN, Navinta Llc, Norvium Bioscience, and Penn Life, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the CARMUSTINE profile page.

The generic ingredient in CARMUSTINE is carmustine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the carmustine profile page.

Summary for 213460

Tradename:	CARMUSTINE
Applicant:	Meitheal
Ingredient:	carmustine
Patents:	0

Medical Subject Heading (MeSH) Categories for 213460

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 213460

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARMUSTINE	carmustine	INJECTABLE;INJECTION	213460	ANDA	Meitheal Pharmaceuticals Inc.	71288-126	71288-126-90	1 KIT in 1 CARTON (71288-126-90) * 30 mL in 1 VIAL, SINGLE-DOSE (71288-124-30) * 3 mL in 1 VIAL (71288-125-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/VIAL
Approval Date:	Aug 2, 2021	TE:	AP	RLD:	No

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