Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203849

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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, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203849
Product Number: 001
Approval Date: Apr 6, 2015
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
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, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203849
Product Number: 002
Approval Date: Apr 6, 2015
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MORPHINE SULFATE (MORPHINE SULFATE)
60MG
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203849
Product Number: 003
Approval Date: Apr 6, 2015
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MORPHINE SULFATE (MORPHINE SULFATE)
100MG
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203849
Product Number: 004
Approval Date: Apr 6, 2015
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MORPHINE SULFATE (MORPHINE SULFATE)
200MG
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203849
Product Number: 005
Approval Date: Apr 6, 2015
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information