
Reset all filters
01 4Lupin Ltd
02 1Medichem S.A
03 83Vertex Pharmaceuticals
04 7Vertex Pharmaceuticals (Australia) Pty. Ltd.
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01 3Antic-calc Tablet, Film Coated
02 1FILM COATED PILL
03 1Film Coated Tablet
04 4Film-coated Tablet
05 6Filmtabl
06 11GRANULE;ORAL
07 11GRANULES
08 2GRANULES IN SACHET
09 2GRANULES;ORAL
10 5Gran
11 2Granules
12 4Granules in a dose bag
13 1Ivacaftor 150Mg 56 Combined Oral Use
14 9TABLET
15 1TABLET; ORAL
16 7TABLET;ORAL
17 3Tablet
18 4tablet
19 18Blank
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01 20Prescription
02 17RX
03 58Blank
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01 2Cafe trio
02 4IVACAFTOR
03 11KALYDECO
04 30Kalydeco
05 10ORKAMBI
06 15Orkambi
07 2SYMDEKO
08 2SYMDEKO (COPACKAGED)
09 3Symdeko
10 8TRIKAFTA
11 4TRIKAFTA (COPACKAGED)
12 3Trikafta
13 1Blank
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01 29Australia
02 20Canada
03 1Italy
04 9Norway
05 1Spain
06 3Sweden
07 11Switzerland
08 21USA
Regulatory Info :
Registration Country : USA
Brand Name : IVACAFTOR
Dosage Form : TABLET; ORAL
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 216074
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IVACAFTOR
Dosage Form : GRANULE;ORAL
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 217431
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IVACAFTOR
Dosage Form : GRANULE;ORAL
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 217431
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IVACAFTOR
Dosage Form : GRANULE;ORAL
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number : 217431
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG
Packaging :
Approval Date : 2012-01-31
Application Number : 203188
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : TABLET;ORAL
Dosage Strength : 125MG;200MG
Packaging :
Approval Date : 2015-07-02
Application Number : 206038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : TABLET;ORAL
Dosage Strength : 125MG;100MG
Packaging :
Approval Date : 2016-09-28
Application Number : 206038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 50MG/PACKET
Packaging :
Approval Date : 2015-03-17
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 75MG/PACKET
Packaging :
Approval Date : 2015-03-17
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 25MG/PACKET
Packaging :
Approval Date : 2019-04-29
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 5.8MG/PACKET
Packaging :
Approval Date : 2023-05-03
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KALYDECO
Dosage Form : GRANULE;ORAL
Dosage Strength : 13.4MG/PACKET
Packaging :
Approval Date : 2023-05-03
Application Number : 207925
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
IVACAFTOR; IVACAFTOR, TEZACAFTOR
Brand Name : SYMDEKO (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG;150MG, 100MG
Packaging :
Approval Date : 2018-02-12
Application Number : 210491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
IVACAFTOR; IVACAFTOR, TEZACAFTOR
Brand Name : SYMDEKO (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 75MG;75MG, 50MG
Packaging :
Approval Date : 2019-06-21
Application Number : 210491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : GRANULE;ORAL
Dosage Strength : 125MG/PACKET;100MG/PACKET
Packaging :
Approval Date : 2018-08-07
Application Number : 211358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : GRANULE;ORAL
Dosage Strength : 188MG/PACKET;150MG/PACKET
Packaging :
Approval Date : 2018-08-07
Application Number : 211358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORKAMBI
Dosage Form : GRANULE;ORAL
Dosage Strength : 94MG/PACKET;75MG/PACKET
Packaging :
Approval Date : 2022-09-02
Application Number : 211358
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG,75MG,50MG; 150MG
Packaging :
Approval Date : 2019-10-21
Application Number : 212273
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG,37.5MG,25MG; 75MG
Packaging :
Approval Date : 2021-06-08
Application Number : 212273
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Brand Name : TRIKAFTA (COPACKAGED)
Dosage Form : GRANULES;ORAL
Dosage Strength : 80MG, 60MG, 40MG;59.5MG
Packaging :
Approval Date : 2023-04-26
Application Number : 217660
Regulatory Info : RX
Registration Country : USA