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Generated: March 26, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 006695

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NDA 006695 describes MUSTARGEN, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. Additional details are available on the MUSTARGEN profile page.

The generic ingredient in MUSTARGEN is mechlorethamine hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.
Summary for 006695
Applicant:Recordati Rare
Ingredient:mechlorethamine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 006695
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 006695
Suppliers and Packaging for NDA: 006695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUSTARGEN mechlorethamine hydrochloride INJECTABLE;INJECTION 006695 NDA RECORDATI RARE DISEASES, INC. 55292-911 55292-911-51 4 VIAL, SINGLE-DOSE in 1 BOX (55292-911-51) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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