Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022195

Expand all

MORPHINE SULFATE (MORPHINE SULFATE)
10MG/5ML
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 10MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N022195
Product Number: 001
Approval Date: Mar 17, 2008
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MORPHINE SULFATE (MORPHINE SULFATE)
20MG/5ML
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 20MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N022195
Product Number: 002
Approval Date: Mar 17, 2008
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MORPHINE SULFATE (MORPHINE SULFATE)
100MG/5ML
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N022195
Product Number: 003
Approval Date: Jan 25, 2010
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information