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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022207

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MORPHINE SULFATE (MORPHINE SULFATE)
15MG
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022207
Product Number: 001
Approval Date: Mar 17, 2008
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
MORPHINE SULFATE (MORPHINE SULFATE)
30MG
Marketing Status: Prescription
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022207
Product Number: 002
Approval Date: Mar 17, 2008
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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