Details for New Drug Application (NDA): 208603
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NDA 208603 describes ARYMO ER, which is a drug marketed by Zyla and is included in one NDA. 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
The generic ingredient in ARYMO ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Twenty-eight 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: | 9,044,402 | 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: | 9,549,899 | 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: | 9,044,402 | 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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