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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
US Department of Justice

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070915

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NDA 070915 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 three suppliers. Additional details are available on the NALBUPHINE HYDROCHLORIDE profile page.

The generic ingredient in NALBUPHINE HYDROCHLORIDE is nalbuphine hydrochloride. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
Summary for 070915
Ingredient:nalbuphine hydrochloride
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 070915
Medical Subject Heading (MeSH) Categories for 070915
Suppliers and Packaging for NDA: 070915
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070915 ANDA Hospira, Inc. 0409-1464 0409-1464-01 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1464-01) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Feb 3, 1989TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo

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