Suppliers and packagers for generic ingredient: ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
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ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
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 | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660 | NDA | Vertex Pharmaceuticals Incorporated | 51167-445-01 | 4 PACKAGE in 1 CARTON (51167-445-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-545-07) * 1 GRANULE in 1 PACKET (51167-645-07) | 2023-04-26 |
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660 | NDA | Vertex Pharmaceuticals Incorporated | 51167-446-01 | 4 PACKAGE in 1 CARTON (51167-446-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-846-07) * 1 GRANULE in 1 PACKET (51167-746-07) | 2023-04-26 |
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | TABLET;ORAL | 212273 | NDA | Vertex Pharmaceuticals Incorporated | 51167-106-02 | 4 BLISTER PACK in 1 CARTON (51167-106-02) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-206-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-306-07) | 2021-06-08 |
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | TABLET;ORAL | 212273 | NDA | Vertex Pharmaceuticals Incorporated | 51167-331-01 | 4 BLISTER PACK in 1 CARTON (51167-331-01) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-431-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-531-07) | 2019-10-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
