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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 070918

NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
20MG/ML
Marketing Status: Prescription
Active Ingredient: NALBUPHINE HYDROCHLORIDE
Proprietary Name: NALBUPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A070918
Product Number: 001
Approval Date: Feb 3, 1989
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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