Product Details for NDA 206544
MORPHABOND ER (MORPHINE SULFATE)
15MG
Marketing Status: Discontinued
30MG
Marketing Status: Discontinued
60MG
Marketing Status: Discontinued
100MG
Marketing Status: Discontinued
15MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 001
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MORPHABOND ER (MORPHINE SULFATE)
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 001
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 002
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MORPHABOND ER (MORPHINE SULFATE)
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 002
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
60MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 003
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MORPHABOND ER (MORPHINE SULFATE)
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 003
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 004
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: MORPHABOND ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206544
Product Number: 004
Approval Date: Oct 2, 2015
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status: Discontinued
Patent and Exclusivity Information