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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213207

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NDA 213207 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 213207

Tradename:	CARMUSTINE
Applicant:	Dr Reddys
Ingredient:	carmustine
Patents:	0

Medical Subject Heading (MeSH) Categories for 213207

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 213207

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARMUSTINE	carmustine	INJECTABLE;INJECTION	213207	ANDA	Dr. Reddy's Laboratories Inc.	43598-628	43598-628-57	1 KIT in 1 CARTON (43598-628-57) * 3 mL in 1 VIAL (43598-860-11) * 30 mL in 1 VIAL, SINGLE-DOSE (43598-861-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/VIAL
Approval Date:	Oct 22, 2020	TE:	AP	RLD:	No

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