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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210179

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NDA 210179 describes CARMUSTINE, which is a drug marketed by Amneal, Navinta Llc, and Sti Pharma Llc, and is included in three NDAs. It is available from four 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. Seven 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) * 30 mL in 1 VIAL, SINGLE-DOSE (70710-1524-1) * 3 mL in 1 VIAL (70710-1523-1)

Profile for product number 001

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

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