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Last Updated: March 28, 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, Mylan Labs Ltd, Navinta Llc, and Penn Life, and is included in twelve NDAs. It is available from twelve 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. Fourteen 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 213207
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:RXDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:Oct 22, 2020TE:APRLD:No

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