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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018565

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DURAMORPH PF (MORPHINE SULFATE)
0.5MG/ML
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: DURAMORPH PF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018565
Product Number: 001
Approval Date: Sep 18, 1984
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DURAMORPH PF (MORPHINE SULFATE)
1MG/ML
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: DURAMORPH PF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018565
Product Number: 002
Approval Date: Sep 18, 1984
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INFUMORPH (MORPHINE SULFATE)
10MG/ML
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: INFUMORPH
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018565
Product Number: 003
Approval Date: Jul 19, 1991
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INFUMORPH (MORPHINE SULFATE)
25MG/ML
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: INFUMORPH
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018565
Product Number: 004
Approval Date: Jul 19, 1991
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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