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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019977

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ORAMORPH SR (MORPHINE SULFATE)
15MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: ORAMORPH SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019977
Product Number: 004
Approval Date: Nov 23, 1994
Applicant Holder Full Name: XANODYNE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ORAMORPH SR (MORPHINE SULFATE)
30MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: ORAMORPH SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019977
Product Number: 001
Approval Date: Aug 15, 1991
Applicant Holder Full Name: XANODYNE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ORAMORPH SR (MORPHINE SULFATE)
60MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: ORAMORPH SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019977
Product Number: 002
Approval Date: Aug 15, 1991
Applicant Holder Full Name: XANODYNE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ORAMORPH SR (MORPHINE SULFATE)
100MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: ORAMORPH SR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019977
Product Number: 003
Approval Date: Aug 15, 1991
Applicant Holder Full Name: XANODYNE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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