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Generated: November 16, 2018

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Details for New Drug Application (NDA): 208603

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NDA 208603 describes ARYMO ER, which is a drug marketed by Egalet and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ARYMO ER profile page.

The generic ingredient in ARYMO ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 208603
Tradename:ARYMO ER
Applicant:Egalet
Ingredient:morphine sulfate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 208603
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 208603
Suppliers and Packaging for NDA: 208603
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603 NDA Egalet US Inc. 69344-111 69344-111-11 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69344-111-11)
ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603 NDA Egalet US Inc. 69344-211 69344-211-11 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69344-211-11)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Jan 9, 2017TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 1, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Patent:➤ Sign UpPatent Expiration:Jul 1, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jan 9, 2017TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 1, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

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