Details for New Drug Application (NDA): 021775
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The generic ingredient in ENTEREG is alvimopan. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the alvimopan profile page.
Summary for 021775
Tradename: | ENTEREG |
Applicant: | Cubist Pharms |
Ingredient: | alvimopan |
Patents: | 1 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 20, 2008 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 12, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A METHOD TO ACCELERATE THE TIME TO GASTROINTESTINAL RECOVERY BY ADMINISTERING ABOUT 12 MG OF ALVIMOPAN TO THE PATIENT FROM ABOUT 30 TO 60 MINUTES PRIOR TO SURGERY |
Expired US Patents for NDA 021775
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cubist Pharms | ENTEREG | alvimopan | CAPSULE;ORAL | 021775-001 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Cubist Pharms | ENTEREG | alvimopan | CAPSULE;ORAL | 021775-001 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Cubist Pharms | ENTEREG | alvimopan | CAPSULE;ORAL | 021775-001 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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