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RLD : Yes
TE Code :
DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
Dosage Form : TABLET; ORAL
Proprietary Name : ALYFTREK
Dosage Strength : 50MG;20MG;EQ 4MG BASE
Approval Date : 2024-12-20
Application Number : 218730
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
Dosage Form : TABLET; ORAL
Proprietary Name : ALYFTREK
Dosage Strength : 125MG;50MG;EQ 10MG BASE
Approval Date : 2024-12-20
Application Number : 218730
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Dosage Form : TABLET; ORAL
Proprietary Name : TRIKAFTA (COPACKAGED)
Dosage Strength : 100MG,75MG,50MG; 150MG
Approval Date : 2019-10-21
Application Number : 212273
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Dosage Form : TABLET; ORAL
Proprietary Name : TRIKAFTA (COPACKAGED)
Dosage Strength : 50MG,37.5MG,25MG; 75MG
Approval Date : 2021-06-08
Application Number : 212273
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Dosage Form : GRANULES; ORAL
Proprietary Name : TRIKAFTA (COPACKAGED)
Dosage Strength : 80MG, 60MG, 40MG;59.5MG
Approval Date : 2023-04-26
Application Number : 217660
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Dosage Form : GRANULES; ORAL
Proprietary Name : TRIKAFTA (COPACKAGED)
Dosage Strength : 100MG, 75MG, 50MG;75MG
Approval Date : 2023-04-26
Application Number : 217660
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : KALYDECO
Dosage Strength : 150MG
Approval Date : 2012-01-31
Application Number : 203188
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : GRANULE; ORAL
Proprietary Name : KALYDECO
Dosage Strength : 50MG/PACKET
Approval Date : 2015-03-17
Application Number : 207925
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : GRANULE; ORAL
Proprietary Name : KALYDECO
Dosage Strength : 75MG/PACKET
Approval Date : 2015-03-17
Application Number : 207925
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : GRANULE; ORAL
Proprietary Name : KALYDECO
Dosage Strength : 25MG/PACKET
Approval Date : 2019-04-29
Application Number : 207925
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Dosage Form : Filmtabl
Dosage Strength : 100mg/50mg/75mg
Packaging :
Brand Name : Trikafta
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Elexacaftorum; Tezacaftorum; Ivacaftorum
Dosage Form : Filmtabl
Dosage Strength : 50mg/25mg/37.5mg
Packaging :
Brand Name : Trikafta
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 200 MG/125 MG
Packaging :
Brand Name : Orkambi
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Dosage Form : Ivacaftor 150Mg 56 Combined Or...
Dosage Strength : 56 cpr riv 150 mg
Packaging :
Brand Name : Kalydeco
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 150 mg
Packaging : Bottle
Brand Name : Kalydeco
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 150 mg
Packaging : Blister
Brand Name : Kalydeco
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Granules
Dosage Strength : 50 mg
Packaging : Dose Bag
Brand Name : Kalydeco
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Granules
Dosage Strength : 75 mg
Packaging : Dose Bag
Brand Name : Kalydeco
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 200MG; 125MG
Packaging : Blister
Brand Name : Orkambi
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtabl
Dosage Strength : 150mg
Packaging :
Brand Name : Kalydeco
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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