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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 214814


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NDA 214814 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 214814
Tradename:CARMUSTINE
Applicant:Msn
Ingredient:carmustine
Patents:0
Medical Subject Heading (MeSH) Categories for 214814
Suppliers and Packaging for NDA: 214814
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARMUSTINE carmustine INJECTABLE;INJECTION 214814 ANDA Novadoz Pharmaceuticals LLC 72205-198 72205-198-01 1 KIT in 1 CARTON (72205-198-01) * 3 mL in 1 VIAL (72205-196-01) * 30 mL in 1 VIAL, SINGLE-DOSE (72205-197-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:May 11, 2023TE:APRLD:No

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