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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Cantor Fitzgerald
Queensland Health
Express Scripts

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075499

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NDA 075499 describes BUTORPHANOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma Farmaceutica, Hospira, West-ward Pharms Int, Apotex Inc, and Mylan, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the BUTORPHANOL TARTRATE profile page.

The generic ingredient in BUTORPHANOL TARTRATE is butorphanol tartrate. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
Summary for 075499
Applicant:Apotex Inc
Ingredient:butorphanol tartrate
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075499
Medical Subject Heading (MeSH) Categories for 075499
Suppliers and Packaging for NDA: 075499
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTORPHANOL TARTRATE butorphanol tartrate SPRAY, METERED;NASAL 075499 ANDA Apotex Corp. 60505-0813 60505-0813-1 1 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) > 2.5 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength1MG/SPRAY
Approval Date:Dec 4, 2002TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Harvard Business School
US Army

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