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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209278

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NDA 209278 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 209278
Applicant:Sti Pharma Llc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209278
Suppliers and Packaging for NDA: 209278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARMUSTINE carmustine INJECTABLE;INJECTION 209278 ANDA STI Pharma LLC 54879-036 54879-036-64 1 KIT in 1 CARTON (54879-036-64) * 30 mL in 1 VIAL, SINGLE-DOSE (54879-023-51) * 3 mL in 1 VIAL (54879-024-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:Apr 2, 2019TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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