01 13Pharmacyclics
02 1Olpha
03 1NanoAlvand
04 1Naprod Life Sciences
05 6Alvogen
06 5Bluepharma
07 2Centocor
08 9Janssen-Cilag
09 12Johnson & Johnson Innovative Medicine
10 1Laboratorio Eczane Pharma
11 2Pluviaendo
12 5Sandoz B2B
13 1Teva Pharmaceutical Industries
14 6Zydus Lifesciences
01 2CAP
02 1CAPSULE
03 10CAPSULE;ORAL
04 3Capsule
05 2Capsule, hard
06 1Capsules
07 3FCT
08 4Film-Coated Tablets
09 1HARD CAPSULES
10 1Hard Gelatin Capsule
11 1Ibrutinib 140Mg 120 Unita' Oral Use
12 1Ibrutinib 140Mg 90 Combined Oral Use
13 1SUSPENSION
14 1SUSPENSION;ORAL
15 20TABLET;ORAL
16 6Tablet
17 7Blank
01 3DISCN
02 1Dossier Readiness: Q1 2026
03 5Originator
04 2Prescription
05 6RX
06 48Blank
01 1Brikatib
02 1Bronib
03 18IBRUTINIB
04 16IMBRUVICA
05 1IMBRUVICA® 140 mg
06 1IMBRUVICA® 420 mg
07 1IMBRUVICA® 560 mg
08 15Imbruvica
09 2Imbruvica 140 mg
10 9Blank
01 1Argentina
02 7Australia
03 2Canada
04 1India
05 1Iran
06 2Italy
07 1Latvia
08 2Norway
09 5Portugal
10 5South Africa
11 1Sweden
12 4Switzerland
13 2Turkey
14 31USA
Regulatory Info : RX
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date : 2013-11-13
Application Number : 205552
Regulatory Info : RX
Registration Country : USA
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Dossier Readiness: Q1 2026
Registration Country : Latvia
Brand Name :
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Readiness: Q1 2026
Registration Country : Latvia
Regulatory Info :
Registration Country : Iran
Brand Name : Bronib
Dosage Form : Hard Gelatin Capsule
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsules
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 70MG
Packaging :
Approval Date : 2017-12-20
Application Number : 205552
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date : 2018-02-16
Application Number : 210563
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 280MG
Packaging :
Approval Date : 2018-02-16
Application Number : 210563
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 420MG
Packaging :
Approval Date : 2018-02-16
Application Number : 210563
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 560MG
Packaging :
Approval Date : 2018-02-16
Application Number : 210563
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 70MG/ML
Packaging :
Approval Date : 2022-08-24
Application Number : 217003
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number : 217003
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number : 217003
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number : 217003
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 230MG
Packaging :
Approval Date :
Application Number : 217003
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 420MG
Packaging :
Approval Date :
Application Number : 217003
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMBRUVICA
Dosage Form : TABLET;ORAL
Dosage Strength : 560MG
Packaging :
Approval Date :
Application Number : 217003
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IBRUTINIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number : 211267
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IBRUTINIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number : 211350
Regulatory Info :
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : IBRUTINIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 70MG
Packaging :
Approval Date : 2021-03-31
Application Number : 211344
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : IBRUTINIB
Dosage Form : CAPSULE;ORAL
Dosage Strength : 140MG
Packaging :
Approval Date : 2021-03-31
Application Number : 211344
Regulatory Info : DISCN
Registration Country : USA
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