Skip to contentApplication 208984
- Type
- NDA
- Sponsor
- VIIV HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SELZENTRY | MARAVIROC | SOLUTION;ORAL | 20MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-237 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-260 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-260 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-260 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-260 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
| 49702-260 | SELZENTRY | maraviroc | ViiV Healthcare Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65141 | SUPPL | 2020-11-03 |
| 65140 | SUPPL | 2020-11-03 |
| 65129 | SUPPL | 2020-11-03 |
| 54933 | SUPPL | 2018-07-20 |
| 54918 | SUPPL | 2018-07-19 |
| 54917 | SUPPL | 2018-07-19 |
| 50200 | ORIG | 2017-10-26 |
| 45861 | ORIG | 2016-11-09 |
| 45847 | ORIG | 2016-11-08 |
| 51324 | ORIG | 1900-01-01 |
| 51323 | ORIG | 1900-01-01 |