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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207595

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NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
10MG/ML
Marketing Status: Discontinued
Active Ingredient: NALBUPHINE HYDROCHLORIDE
Proprietary Name: NALBUPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A207595
Product Number: 001
Approval Date: Jan 11, 2019
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
20MG/ML
Marketing Status: Discontinued
Active Ingredient: NALBUPHINE HYDROCHLORIDE
Proprietary Name: NALBUPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A207595
Product Number: 002
Approval Date: Jan 11, 2019
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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