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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Argus Health
Harvard Business School

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070916

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NDA 070916 describes NALBUPHINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abbvie, Barr, Hospira, and Igi Labs Inc, and is included in thirteen NDAs. It is available from four suppliers. Additional details are available on the NALBUPHINE HYDROCHLORIDE profile page.

The generic ingredient in NALBUPHINE HYDROCHLORIDE is nalbuphine hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
Summary for 070916
Ingredient:nalbuphine hydrochloride
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 070916
Medical Subject Heading (MeSH) Categories for 070916
Suppliers and Packaging for NDA: 070916
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070916 ANDA Hospira, Inc. 0409-1465 N 0409-1465-01
NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070916 ANDA McKesson Packaging Services Business Unit of McKesson Corporation 63739-466 E 63739-466-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Feb 3, 1989TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Argus Health
Cantor Fitzgerald
Express Scripts
Daiichi Sankyo

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