Application 206038
- Type
- NDA
- Sponsor
- VERTEX PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORKAMBI | IVACAFTOR; LUMACAFTOR | TABLET;ORAL | 125MG;200MG | Yes | Yes |
| 002 | ORKAMBI | IVACAFTOR; LUMACAFTOR | TABLET;ORAL | 125MG;100MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51167-700 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-700 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-700 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-700 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-700 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-700 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-809 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-809 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-809 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-809 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-809 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
| 51167-809 | ORKAMBI | lumacaftor and ivacaftor | Vertex Pharmaceuticals Incorporated | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85475 | SUPPL | 2026-03-24 |
| 85411 | SUPPL | 2026-03-19 |
| 83564 | SUPPL | 2025-09-26 |
| 83552 | SUPPL | 2025-09-26 |
| 80594 | SUPPL | 2024-12-16 |
| 80580 | SUPPL | 2024-12-16 |
| 74994 | SUPPL | 2023-08-04 |
| 74987 | SUPPL | 2023-08-04 |
| 72036 | SUPPL | 2022-09-07 |
| 72017 | SUPPL | 2022-09-06 |
| 55211 | SUPPL | 2018-08-20 |
| 55192 | SUPPL | 2018-08-17 |
| 52425 | SUPPL | 2018-02-06 |
| 52097 | SUPPL | 2018-01-30 |
| 47284 | SUPPL | 2017-02-22 |
| 45500 | SUPPL | 2016-09-30 |
| 45277 | SUPPL | 2016-09-07 |
| 40522 | SUPPL | 2016-05-20 |
| 10540 | SUPPL | 2016-05-20 |
| 24509 | ORIG | 2015-08-07 |
| 23011 | ORIG | 2015-08-07 |
| 19701 | ORIG | 2015-07-02 |
| 10539 | ORIG | 2015-07-02 |