Application 209394
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAVYRET | GLECAPREVIR; PIBRENTASVIR | TABLET;ORAL | 100MG;40MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
| 0074-2625 | Mavyret | Glecaprevir and Pibrentasvir | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85649 | SUPPL | 2026-04-07 |
| 85648 | SUPPL | 2026-04-07 |
| 82544 | SUPPL | 2025-06-12 |
| 82534 | SUPPL | 2025-06-11 |
| 75973 | SUPPL | 2023-10-27 |
| 75948 | SUPPL | 2023-10-26 |
| 68862 | SUPPL | 2021-10-01 |
| 68804 | SUPPL | 2021-09-29 |
| 67778 | SUPPL | 2021-06-14 |
| 67768 | SUPPL | 2021-06-11 |
| 62548 | SUPPL | 2020-04-13 |
| 62544 | SUPPL | 2020-04-13 |
| 60205 | SUPPL | 2019-10-02 |
| 60204 | SUPPL | 2019-10-02 |
| 60142 | SUPPL | 2019-09-27 |
| 60141 | SUPPL | 2019-09-27 |
| 58503 | SUPPL | 2019-05-01 |
| 58484 | SUPPL | 2019-04-30 |
| 55130 | SUPPL | 2018-08-07 |
| 55124 | SUPPL | 2018-08-07 |
| 50719 | SUPPL | 2017-12-18 |
| 50676 | SUPPL | 2017-12-13 |
| 49723 | ORIG | 2017-09-13 |
| 49722 | ORIG | 2017-09-13 |
| 49257 | ORIG | 2017-08-07 |
| 49251 | ORIG | 2017-08-07 |
| 63051 | SUPPL | 1900-01-01 |
| 63049 | SUPPL | 1900-01-01 |
| 63048 | SUPPL | 1900-01-01 |
| 63047 | SUPPL | 1900-01-01 |
| 63046 | SUPPL | 1900-01-01 |