01 15Vertex Pharmaceuticals
01 1Antic-calc Tablet, Film Coated
02 2Filmtabl
03 3GRANULE;ORAL
04 3GRANULES
05 2Gran
06 2TABLET
07 2TABLET;ORAL
01 5Prescription
02 5RX
03 5Blank
01 10ORKAMBI
02 5Orkambi
01 5Canada
02 1Norway
03 4Switzerland
04 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 : 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 : 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 : 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
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