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 3CYCLE PHARMACEUTICALS LTD.
03 5Cycle Pharmaceuticals
04 15Dipharma
05 4Eton Pharmaceuticals
06 4MEDUNIK CANADA
07 10Mendeli Kabs
08 2Nobel Ilac Sanayii Ve Ticaret A.S.
09 3Novitium Pharma LLC
10 32Swedish Orphan Biovitrum AB
11 4Torrent Pharmaceuticals Limited
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01 7CAPSULE
02 19CAPSULE;ORAL
03 17Capsule
04 4Capsule, hard
05 11Hard Capsule
06 3Hard Capsule For Oral Use
07 1Hard Capsule Oral Use Hdpe
08 4Hard Capsules
09 1Nitisinone 10Mg 60 Units Oral Use
10 1Nitisinone 2Mg 60 Units Oral Use
11 1Nitisinone 5Mg 60 Units Oral Use
12 2Oral Suspension
13 1Potion, suspension
14 1SUSPENSION
15 1SUSPENSION;ORAL
16 3TABLET
17 4TABLET;ORAL
18 4Tablet
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01 9Approved
02 12Authorized
03 4DISCN
04 5Deregistered
05 11Prescription
06 20RX
07 24Blank
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01 3Disanit
02 1HARLIKU
03 3MDK-NITISINONE
04 15NITISINONE
05 4NITISINONE DIPHARMA
06 3NITISINONE TABLETS
07 3NITYR
08 4Nitisinona Dipharma
09 3Nitisinone
10 4Nitisinone Dipharma
11 7Nitisinone Mdk
12 1Nittyr
13 14ORFADIN
14 18Orfadin
15 2Tisinon
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01 11Canada
02 3India
03 14Italy
04 5Norway
05 12Spain
06 14Sweden
07 2Turkey
08 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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