Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206544

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MORPHABOND ER (MORPHINE SULFATE)
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)
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)
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)
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