Application 021775
- Type
- NDA
- Sponsor
- CUBIST PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENTEREG | ALVIMOPAN | CAPSULE;ORAL | 12MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-020 | Entereg | alvimopan | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76410 | ORIG | 2023-11-06 |
| 74479 | SUPPL | 2023-06-13 |
| 65281 | SUPPL | 2020-11-19 |
| 65262 | SUPPL | 2020-11-18 |
| 61411 | SUPPL | 2019-12-23 |
| 60541 | SUPPL | 2019-10-11 |
| 60533 | SUPPL | 2019-10-11 |
| 6163 | SUPPL | 2016-05-20 |
| 37624 | SUPPL | 2013-10-22 |
| 28576 | SUPPL | 2013-10-21 |
| 28575 | SUPPL | 2012-10-23 |
| 37623 | SUPPL | 2012-10-22 |
| 6162 | SUPPL | 2012-10-02 |
| 6161 | SUPPL | 2010-01-21 |
| 37622 | SUPPL | 2009-11-19 |
| 6160 | SUPPL | 2009-02-19 |
| 21814 | ORIG | 2008-07-18 |
| 44649 | ORIG | 2008-07-17 |
| 24010 | ORIG | 2008-05-28 |
| 16353 | ORIG | 2008-05-28 |
| 6159 | ORIG | 2008-05-28 |