Application 207865
- Type
- NDA
- Sponsor
- MSD MERCK CO
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMEND | APREPITANT | FOR SUSPENSION;ORAL | 125MG/KIT | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3066 | EMEND | aprepitant | Merck Sharp & Dohme Corp. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 60854 | SUPPL | 2019-11-15 |
| 60844 | SUPPL | 2019-11-15 |
| 60126 | SUPPL | 2019-09-26 |
| 60116 | SUPPL | 2019-09-26 |
| 48634 | SUPPL | 2017-06-02 |
| 48617 | SUPPL | 2017-06-01 |
| 46071 | ORIG | 2016-09-30 |
| 40593 | ORIG | 2015-12-18 |
| 10622 | ORIG | 2015-12-18 |
| 66724 | ORIG | 1900-01-01 |
| 66723 | ORIG | 1900-01-01 |
| 66722 | ORIG | 1900-01-01 |
| 66721 | ORIG | 1900-01-01 |
| 66720 | ORIG | 1900-01-01 |
| 66719 | ORIG | 1900-01-01 |
| 51603 | ORIG | 1900-01-01 |
| 51602 | ORIG | 1900-01-01 |
| 51591 | ORIG | 1900-01-01 |
| 51590 | ORIG | 1900-01-01 |