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01 8Biogen
02 10Celltrion
03 107F. Hoffmann-La Roche
04 11Fresenius Kabi AB Brunna
05 5Fresenius Kabi Austria
06 4Fresenius Kabi USA
07 4Genentech
08 2Health Biotech
09 5Iqone Healthcare Switzerland Sa
10 4Roche Diagnostics GmbH
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01 5Concentrate For Infusion Solution
02 10Concentrate For Solution For Infusion
03 3INF
04 3INJECTABLE; INJECTION
05 3INJECTABLE;INJECTION
06 6INJECTABLE;INTRAVENOUS
07 1INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
08 2INJECTABLE;SUBCUTANEOUS
09 1Injectable Solution In A Pre-Filled Pen
10 3Injectable Solution In Pre-Filled Pen
11 4Injectable Solution In Pre-Filled Syringe
12 2Injection
13 1PFS
14 10SOLUTION
15 11Solution For Injection
16 3Solution for infusion
17 1Solution for injection in a pre-filled pen
18 1Solution for injection, solution in pre-filled syringe
19 90Blank
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01 13Allowed
02 10Approved
03 11Authorized
04 4Originator
05 4Prescription
06 6Schedule D
07 112Blank
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01 9ACTEMRA
02 4AVTOZMA
03 57Actemra
04 2Actemra
05 1Actemra 200
06 1Actemra 400
07 1Actemra 80
08 18Actemra ACTPen
09 1Actemra SC
10 18Actemra Subcutaneous Injection
11 3Autozma
12 5Avtozma
13 3Avtozma
14 7Roactemra
15 3TOFIDENCE
16 9TYENNE
17 5Tofidence
18 5Tyene
19 6Tyenne
20 2Blank
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01 90Australia
02 10Canada
03 2India
04 5Norway
05 4South Africa
06 11Spain
07 10Sweden
08 13Switzerland
09 15USA
Regulatory Info :
Registration Country : USA
Brand Name : TOFIDENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 80MG/4ML
Packaging :
Approval Date :
Application Number : 761354
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TOFIDENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number : 761354
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TOFIDENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 761354
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AVTOZMA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 80MG/4ML(20MG/ML)
Packaging :
Approval Date :
Application Number : 761420
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AVTOZMA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 200MG/10ML(20MG/ML)
Packaging :
Approval Date :
Application Number : 761420
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AVTOZMA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 400MG/20ML(20MG/ML)
Packaging :
Approval Date :
Application Number : 761420
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AVTOZMA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 162MG/0.9ML
Packaging :
Approval Date :
Application Number : 761420
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for injection, solution in pre-filled syringe
Dosage Strength : 162 mg
Packaging : Pre-filled glass syringe 4 0.9ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 162 mg
Packaging : Pre-filled pen 4 0.9ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for infusion
Dosage Strength : 20 mg/ml
Packaging : Vials 1 4ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 80MG/4ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 162MG/0.9ML
Packaging :
Approval Date :
Application Number : 761449
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 80MG/4ML
Packaging :
Approval Date :
Application Number : 125276
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number : 125276
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 125276
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 162MG/0.9ML
Packaging :
Approval Date :
Application Number : 125472
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India