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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070918

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NDA 070918 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 070918

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 070918

Medical Subject Heading (MeSH) Categories for 070918

Suppliers and Packaging for NDA: 070918

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070918 ANDA Hospira, Inc. 0409-1467 0409-1467-01 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1467-01) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

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


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Boehringer Ingelheim
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