Application 208624
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIEKIRA XR | DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE;8.33MG;50MG;33.33MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-0063 | Viekira | Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-0063 | Viekira | Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir | AbbVie Inc. | NDA | Current |
| 0074-0063 | Viekira | Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61209 | SUPPL | 2019-12-10 |
| 61199 | SUPPL | 2019-12-09 |
| 61198 | SUPPL | 2019-12-09 |
| 55359 | SUPPL | 2018-08-29 |
| 55358 | SUPPL | 2018-08-29 |
| 54993 | SUPPL | 2018-07-26 |
| 50380 | SUPPL | 2017-11-13 |
| 48850 | ORIG | 2017-06-28 |
| 47672 | SUPPL | 2017-03-24 |
| 47671 | SUPPL | 2017-03-24 |
| 47641 | SUPPL | 2017-03-23 |
| 47640 | SUPPL | 2017-03-23 |
| 47225 | SUPPL | 2017-02-15 |
| 47210 | SUPPL | 2017-02-15 |
| 32913 | ORIG | 2016-07-26 |
| 19999 | ORIG | 2016-07-25 |