Details for New Drug Application (NDA): 208603
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The generic ingredient in ARYMO ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 208603
Tradename: | ARYMO ER |
Applicant: | Zyla |
Ingredient: | morphine sulfate |
Patents: | 2 |
Medical Subject Heading (MeSH) Categories for 208603
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Jan 9, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2033 | Product Flag? | Y | Substance 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 Up | Patent Expiration: | Jul 1, 2033 | Product Flag? | Y | Substance 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: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 9, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2033 | Product Flag? | Y | Substance 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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