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01 16Vertex Pharmaceuticals
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01 1Antic-calc Tablet, Film Coated
02 2Film Coated Tablet
03 3GRANULE;ORAL
04 3GRANULES
05 3Granule In Sachet
06 2TABLET
07 2TABLET;ORAL
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01 5Authorized
02 5Prescription
03 5RX
04 1Blank
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01 10ORKAMBI
02 5Orcambi
03 1Orkambi
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01 5Canada
02 1Norway
03 5Spain
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 : 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 : 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 : GRANULES
Dosage Strength : 75MG/SACHET
Packaging :
Approval Date :
Application Number : 2537087
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Orcambi
Dosage Form : Granule In Sachet
Dosage Strength : 150MG; 188 MG
Packaging :
Approval Date : 2019-02-28
Application Number : 1151059007
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Orcambi
Dosage Form : Granule In Sachet
Dosage Strength : 75MG; 94 MG
Packaging :
Approval Date : 2023-07-26
Application Number : 1151059008
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Orcambi
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG; 125 MG
Packaging :
Approval Date : 2016-07-07
Application Number : 1151059001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Orcambi
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG; 125 MG
Packaging :
Approval Date : 2018-04-05
Application Number : 1151059005
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Orcambi
Dosage Form : Granule In Sachet
Dosage Strength : 100MG; 125 MG
Packaging :
Approval Date : 2019-02-28
Application Number : 1151059006
Regulatory Info : Authorized
Registration Country : Spain