Details for New Drug Application (NDA): 070914

NDA 070914 describes NALBUPHINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Somerset Theraps Llc, and is included in seventeen NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.

Summary for 070914

Tradename:	NALBUPHINE HYDROCHLORIDE
Applicant:	Hospira
Ingredient:	nalbuphine hydrochloride
Patents:	0

Pharmacology for NDA: 070914

Mechanism of Action

Competitive Opioid Antagonists Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for 070914

Analgesics, Opioid

Narcotic Antagonists

Narcotics

Suppliers and Packaging for NDA: 070914

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	070914	ANDA	Henry Schein, Inc.	0404-9918	0404-9918-01	1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULE
NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	070914	ANDA	Hospira, Inc.	0409-1463	0409-1463-01	10 AMPULE in 1 TRAY (0409-1463-01) / 1 mL in 1 AMPULE (0409-1463-71)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Feb 3, 1989	TE:	AP	RLD:	No

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