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20-22 May, 2025
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25-30 April, 2025
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27-30 April, 2025
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11 Apr 2025
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01 Apr 2025
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28 Mar 2025
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https://www.businesswire.com/news/home/20250328622122/en/Vertex-Announces-Program-Updates-for-Type-1-Diabetes-Portfolio
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 :
Inspections and registrations
Name and address of WHO GMP certified Manufacturer : M/s Vertex Pharma chemicals Puducherry
Country : U.S.A
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