Suppliers and packages for generic ingredient: IVACAFTOR; LUMACAFTOR
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IVACAFTOR; LUMACAFTOR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358 | NDA | Vertex Pharmaceuticals Incorporated | 51167-122-01 | 56 PACKET in 1 CARTON (51167-122-01) / 1 GRANULE in 1 PACKET | 2022-09-02 |
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358 | NDA | Vertex Pharmaceuticals Incorporated | 51167-500-02 | 56 PACKET in 1 CARTON (51167-500-02) / 1 GRANULE in 1 PACKET | 2018-08-07 |
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358 | NDA | Vertex Pharmaceuticals Incorporated | 51167-900-01 | 56 PACKET in 1 CARTON (51167-900-01) / 1 GRANULE in 1 PACKET | 2018-08-07 |
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-700-02 | 4 CARTON in 1 BOX (51167-700-02) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK | 2016-09-28 |
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-809-01 | 4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK | 2015-07-02 |
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