Application 207931
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TECHNIVIE | OMBITASVIR; PARITAPREVIR; RITONAVIR | TABLET;ORAL | 12.5MG;75MG;50MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-3082 | Technivie | Ombitasvir and Paritaprevir and Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3082 | Technivie | Ombitasvir and Paritaprevir and Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-3082 | Technivie | Ombitasvir and Paritaprevir and Ritonavir | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61208 | SUPPL | 2019-12-10 |
| 61195 | SUPPL | 2019-12-09 |
| 61194 | SUPPL | 2019-12-09 |
| 55363 | SUPPL | 2018-08-29 |
| 55361 | SUPPL | 2018-08-29 |
| 54974 | SUPPL | 2018-07-25 |
| 50379 | SUPPL | 2017-11-13 |
| 47677 | SUPPL | 2017-03-24 |
| 47676 | SUPPL | 2017-03-24 |
| 47645 | SUPPL | 2017-03-23 |
| 47644 | SUPPL | 2017-03-23 |
| 47441 | SUPPL | 2017-03-03 |
| 47369 | SUPPL | 2017-02-28 |
| 47222 | SUPPL | 2017-02-15 |
| 47211 | SUPPL | 2017-02-15 |
| 40599 | SUPPL | 2016-06-23 |
| 10631 | SUPPL | 2016-06-23 |
| 43538 | ORIG | 2016-05-25 |
| 40598 | SUPPL | 2016-02-01 |
| 32865 | SUPPL | 2016-01-29 |
| 10630 | SUPPL | 2015-10-26 |
| 40597 | SUPPL | 2015-10-23 |
| 40596 | ORIG | 2015-07-24 |
| 10629 | ORIG | 2015-07-24 |