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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020207

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NDA 020207 describes ALKERAN, which is a drug marketed by Apotex Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the ALKERAN profile page.

The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the melphalan profile page.

Summary for NDA: 020207

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020207

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
melphalan hydrochloride
INJECTABLE;INJECTION 020207 NDA Apo-Pharma USA, Inc 52609-3001 52609-3001-0 1 KIT in 1 CARTON (52609-3001-0) * 10 mL in 1 VIAL, SINGLE-DOSE (52609-3002-0) * 10 mL in 1 VIAL, SINGLE-USE (52609-3003-0)

Summary for product number 001

Approval Date:Nov 18, 1992TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020207

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Inc
melphalan hydrochloride
INJECTABLE;INJECTION020207-001Nov 18, 19924,997,651► Subscribe
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