Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208603

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ARYMO ER (MORPHINE SULFATE)
15MG Marketing Status: Discontinued

Active Ingredient: MORPHINE SULFATE
Proprietary Name: ARYMO ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208603
Product Number: 001
Approval Date: Jan 9, 2017
Applicant Holder Full Name: EGALET US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ARYMO ER (MORPHINE SULFATE)
30MG Marketing Status: Discontinued

Active Ingredient: MORPHINE SULFATE
Proprietary Name: ARYMO ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208603
Product Number: 002
Approval Date: Jan 9, 2017
Applicant Holder Full Name: EGALET US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ARYMO ER (MORPHINE SULFATE)
60MG Marketing Status: Discontinued

Active Ingredient: MORPHINE SULFATE
Proprietary Name: ARYMO ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208603
Product Number: 003
Approval Date: Jan 9, 2017
Applicant Holder Full Name: EGALET US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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