Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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01 3Omgene Life Sciences Pvt. Ltd
02 5Cycle Pharmaceuticals
03 19Dipharma
04 4Eton Pharmaceuticals
05 4MEDUNIK CANADA
06 10Mendeli Kabs
07 2Nobel Ilac Sanayii Ve Ticaret A.S.
08 3Novitium Pharma LLC
09 37Swedish Orphan Biovitrum AB
10 4Torrent Pharmaceuticals Limited
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01 7CAPSULE
02 19CAPSULE;ORAL
03 29Capsule
04 11Hard Capsule
05 3Hard Capsule For Oral Use
06 1Hard Capsule Oral Use Hdpe
07 4Hard Capsules
08 1Nitisinone 10Mg 60 Units Oral Use
09 1Nitisinone 2Mg 60 Units Oral Use
10 1Nitisinone 5Mg 60 Units Oral Use
11 4Oral Suspension
12 1SUSPENSION
13 1SUSPENSION;ORAL
14 4TABLET;ORAL
15 4Tablet
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01 9Approved
02 12Authorized
03 4DISCN
04 5Deregistered
05 9Marketed
06 13Prescription
07 20RX
08 19Blank
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01 3Disanit
02 1HARLIKU
03 3MDK-NITISINONE
04 15NITISINONE
05 4NITISINONE DIPHARMA
06 3NITYR
07 4Nitisinona Dipharma
08 3Nitisinone
09 8Nitisinone Dipharma
10 7Nitisinone Mdk
11 1Nittyr
12 14ORFADIN
13 23Orfadin
14 2Tisinon
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01 8Canada
02 5Estonia
03 3India
04 14Italy
05 9Norway
06 12Spain
07 14Sweden
08 2Turkey
09 24USA
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name : Nitisinone
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name : Nitisinone
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name : Nitisinone
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Regulatory Info : RX
Registration Country : USA
Brand Name : NITYR
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2017-07-26
Application Number : 209449
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITYR
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2017-07-26
Application Number : 209449
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITYR
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2017-07-26
Application Number : 209449
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : HARLIKU
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2025-06-10
Application Number : 209449
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2022-05-26
Application Number : 212390
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2022-05-26
Application Number : 212390
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2022-05-26
Application Number : 212390
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-04-27
Application Number : 212390
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2019-08-26
Application Number : 211041
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2019-08-26
Application Number : 211041
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2019-08-26
Application Number : 211041
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : ORFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2002-01-18
Application Number : 21232
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : ORFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2002-01-18
Application Number : 21232
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : ORFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2002-01-18
Application Number : 21232
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : ORFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2016-06-13
Application Number : 21232
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : ORFADIN
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 4MG/ML
Packaging :
Approval Date : 2016-04-22
Application Number : 206356
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2023-01-09
Application Number : 215908
Regulatory Info : DISCN
Registration Country : USA
