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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210179


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NDA 210179 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 210179
Tradename:CARMUSTINE
Applicant:Navinta Llc
Ingredient:carmustine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210179
Suppliers and Packaging for NDA: 210179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARMUSTINE carmustine INJECTABLE;INJECTION 210179 ANDA Navinta LLC 68475-503 68475-503-01 1 KIT in 1 CARTON (68475-503-01) * 3 mL in 1 VIAL (68475-502-01) * 30 mL in 1 VIAL, SINGLE-DOSE (68475-500-01)
CARMUSTINE carmustine INJECTABLE;INJECTION 210179 ANDA Zydus Pharmaceuticals USA Inc. 70710-1525 70710-1525-9 1 KIT in 1 CARTON (70710-1525-9) * 3 mL in 1 VIAL (70710-1523-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70710-1524-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:Sep 11, 2018TE:APRLD:No

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