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01 2DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
02 4ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
03 6IVACAFTOR
04 2IVACAFTOR; IVACAFTOR, TEZACAFTOR
05 5IVACAFTOR; LUMACAFTOR
06 1TELAPREVIR
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01 8GRANULE;ORAL
02 2GRANULES;ORAL
03 10TABLET;ORAL
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01 1100MG, 75MG, 50MG;75MG
02 1100MG,75MG,50MG; 150MG
03 1125MG/PACKET;100MG/PACKET
04 1125MG;100MG
05 1125MG;200MG
06 1125MG;50MG;EQ 10MG BASE
07 113.4MG/PACKET
08 1150MG
09 1150MG;150MG, 100MG
10 1188MG/PACKET;150MG/PACKET
11 125MG/PACKET
12 1375MG
13 15.8MG/PACKET
14 150MG,37.5MG,25MG; 75MG
15 150MG/PACKET
16 150MG;20MG;EQ 4MG BASE
17 175MG/PACKET
18 175MG;75MG, 50MG
19 180MG, 60MG, 40MG;59.5MG
20 194MG/PACKET;75MG/PACKET
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01 1DISCN
02 19RX
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 :