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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216899

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HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
0.2MG/ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216899
Product Number: 001
Approval Date: Feb 9, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
0.5MG/0.5ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5MG/0.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216899
Product Number: 002
Approval Date: Feb 9, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
1MG/ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216899
Product Number: 003
Approval Date: Feb 9, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
2MG/ML
Marketing Status: Prescription
Active Ingredient: HYDROMORPHONE HYDROCHLORIDE
Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A216899
Product Number: 004
Approval Date: Feb 9, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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