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Generated: December 15, 2017

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 five 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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0409-1465-01 10 AMPULE in 1 TRAY (0409-1465-01) > 1 mL in 1 AMPULE
NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070916 ANDA McKesson Packaging Services Business Unit of McKesson Corporation 63739-466 63739-466-05 5 POUCH in 1 BOX (63739-466-05) > 1 AMPULE in 1 POUCH (63739-466-21) > 1 mL in 1 AMPULE

Summary for product number 001

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


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