01 4ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
02 6IVACAFTOR
03 2IVACAFTOR; IVACAFTOR, TEZACAFTOR
04 5IVACAFTOR; LUMACAFTOR
05 1TELAPREVIR
01 8GRANULE;ORAL
02 2GRANULES;ORAL
03 8TABLET;ORAL
01 1100MG, 75MG, 50MG;75MG
02 1100MG,75MG,50MG; 150MG
03 1125MG/PACKET;100MG/PACKET
04 1125MG;100MG
05 1125MG;200MG
06 113.4MG/PACKET
07 1150MG
08 1150MG;150MG, 100MG
09 1188MG/PACKET;150MG/PACKET
10 125MG/PACKET
11 1375MG
12 15.8MG/PACKET
13 150MG,37.5MG,25MG; 75MG
14 150MG/PACKET
15 175MG/PACKET
16 175MG;75MG, 50MG
17 180MG, 60MG, 40MG;59.5MG
18 194MG/PACKET;75MG/PACKET
01 1DISCN
02 17RX
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 :
RLD : Yes
TE Code :
Dosage Form : GRANULE; ORAL
Proprietary Name : KALYDECO
Dosage Strength : 5.8MG/PACKET
Approval Date : 2023-05-03
Application Number : 207925
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : GRANULE; ORAL
Proprietary Name : KALYDECO
Dosage Strength : 13.4MG/PACKET
Approval Date : 2023-05-03
Application Number : 207925
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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