Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 3Omgene Life Sciences Pvt. Ltd
02 3CYCLE PHARMACEUTICALS LTD.
03 3Cycle Pharmaceuticals
04 7Dipharma
05 4Eton Pharmaceuticals
06 4MEDUNIK CANADA
07 3Mendeli Kabs
08 2Nobel Ilac Sanayii Ve Ticaret A.S.
09 3Novitium Pharma LLC
10 27Swedish Orphan Biovitrum AB
11 4Torrent Pharmaceuticals Limited
01 7CAPSULE
02 19CAPSULE;ORAL
03 5Capsule
04 4Capsule, hard
05 3Hard Capsule For Oral Use
06 1Hard Capsule Oral Use Hdpe
07 4Hard Capsules
08 4KAPSEL, HÅRD
09 1Nitisinone 10Mg 60 Units Oral Use
10 1Nitisinone 2Mg 60 Units Oral Use
11 1Nitisinone 5Mg 60 Units Oral Use
12 1ORAL SUSPENSION
13 1Potion, suspension
14 1SUSPENSION
15 1SUSPENSION;ORAL
16 3TABLET
17 3TABLET;ORAL
18 3Tablet
01 4DISCN
02 11Prescription
03 19RX
04 29Blank
01 3Disanit
02 3MDK-NITISINONE
03 15NITISINONE
04 4NITISINONE DIPHARMA
05 3NITISINONE TABLETS
06 3NITYR
07 14ORFADIN
08 13Orfadin
09 2Tisinon
10 3Blank
01 11Canada
02 3India
03 14Italy
04 5Norway
05 5Sweden
06 2Turkey
07 23USA
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
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 :
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 :
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 : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2023-05-25
Application Number : 216201
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 : 2023-05-25
Application Number : 216201
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 : 2023-05-25
Application Number : 216201
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 : 2023-05-25
Application Number : 216201
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 :
Registration Country : Sweden
Brand Name : Orfadin
Dosage Form : KAPSEL, HÅRD
Dosage Strength : 20 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Orfadin
Dosage Form : KAPSEL, HÅRD
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Orfadin
Dosage Form : ORAL SUSPENSION
Dosage Strength : 4 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Orfadin
Dosage Form : KAPSEL, HÅRD
Dosage Strength : 2 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2023-01-09
Application Number : 215908
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2023-01-09
Application Number : 215908
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NITISINONE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-01-09
Application Number : 215908
Regulatory Info : DISCN
Registration Country : USA
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