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Details for New Drug Application (NDA): 070915

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NDA 070915 describes NALBUPHINE HYDROCHLORIDE, which is a drug marketed by Abbvie, Hospira, Abbott, Igi Labs Inc, and Barr, 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 NDA: 070915

nalbuphine hydrochloride
Therapeutic Class:Analgesics

Pharmacology for NDA: 070915

Suppliers and Packaging for NDA: 070915

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Feb 3, 1989TE:APRLD:Yes

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