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01 25Vertex Pharmaceuticals
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01 1Antic-calc Tablet, Film Coated
02 4Film-coated Tablet
03 2Filmtabl
04 3GRANULE;ORAL
05 3GRANULES
06 2Gran
07 2TABLET
08 2TABLET;ORAL
09 6Blank
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01 5Prescription
02 5RX
03 15Blank
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01 10ORKAMBI
02 15Orkambi
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01 10Australia
02 5Canada
03 1Norway
04 4Switzerland
05 5USA
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 : 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 :
Registration Country : Norway
Brand Name : Orkambi
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 200MG; 125MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Orkambi
Dosage Form : Filmtabl
Dosage Strength : 100mg/125mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Orkambi
Dosage Form : Gran
Dosage Strength : 100mg/125mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Orkambi
Dosage Form : Gran
Dosage Strength : 150mg/188mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Orkambi
Dosage Form : Filmtabl
Dosage Strength : 200mg/125mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ORKAMBI
Dosage Form : GRANULES
Dosage Strength : 100MG/SACHET
Packaging :
Approval Date :
Application Number : 2483831
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ORKAMBI
Dosage Form : GRANULES
Dosage Strength : 150MG/SACHET
Packaging :
Approval Date :
Application Number : 2483858
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ORKAMBI
Dosage Form : TABLET
Dosage Strength : 200MG
Packaging : 112
Approval Date :
Application Number : 2451379
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ORKAMBI
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging : 28/112
Approval Date :
Application Number : 2463040
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ORKAMBI
Dosage Form : GRANULES
Dosage Strength : 75MG/SACHET
Packaging :
Approval Date :
Application Number : 2537087
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Orkambi
Dosage Form : Film-coated Tablet
Dosage Strength : 100MG
Packaging : 112
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orkambi
Dosage Form : Film-coated Tablet
Dosage Strength : 200MG
Packaging : 112
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orkambi
Dosage Form : Film-coated Tablet
Dosage Strength : 200MG
Packaging : 112
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orkambi
Dosage Form : Film-coated Tablet
Dosage Strength : 100MG
Packaging : 112
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orkambi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia