Application 201699
- Type
- NDA
- Sponsor
- CUBIST PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIFICID | FIDAXOMICIN | TABLET;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme LLC | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme LLC | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
| 52015-080 | Dificid | fidaxomicin | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63359 | SUPPL | 2020-06-01 |
| 63349 | SUPPL | 2020-05-29 |
| 61696 | SUPPL | 2020-01-27 |
| 61660 | SUPPL | 2020-01-27 |
| 58253 | SUPPL | 2019-04-08 |
| 58244 | SUPPL | 2019-04-08 |
| 58025 | SUPPL | 2019-03-18 |
| 58011 | SUPPL | 2019-03-18 |
| 9927 | SUPPL | 2015-02-26 |
| 32130 | SUPPL | 2013-04-09 |
| 19032 | SUPPL | 2013-04-09 |
| 43372 | ORIG | 2011-06-28 |
| 24400 | ORIG | 2011-06-28 |
| 40083 | ORIG | 2011-05-31 |
| 9926 | ORIG | 2011-05-31 |
| 66498 | ORIG | 1900-01-01 |
| 63918 | ORIG | 1900-01-01 |