Aspen API. More than just an API™
01 5Aspen API
02 7Aspen Pharmacare Holdings
03 6Dr. Reddy's Laboratories
04 4Aurobindo Pharma Limited
05 1BrightGene Bio-Medical Technology Co.,Ltd
06 1Farmak JSC
07 5GSK
08 4Hangzhou Zhongmei Huadong Pharmaceutical
09 8Jiangsu Hengrui Medicine
10 1Lotus Pharmaceutical Industries
11 4ScinoPharm Taiwan Ltd
12 35Viatris
13 4XYZ Pharma
01 1Fondaparinux 1,5Mg 0,3Ml 10 Units Parenteral Use
02 1Fondaparinux 10Mg 0,8Ml 10 Units Parenteral Use
03 1Fondaparinux 2,5Mg 0,5Ml 10 Inita' Parenteral Use
04 1Fondaparinux 5Mg 0.4 Ml 10 Units Parenteral Use
05 1Fondaparinux 7,5Mg 0,6Ml 10 Units Parenteral Use
06 4INJ
07 25INJECTABLE;SUBCUTANEOUS
08 5Injectable Solution In Pre-Filled Syringe
09 3Injectable Solution in Pre-Filled Syringe
10 9Injection
11 1Prefilled Syringe
12 4SOLUTION
13 28Solution For Injection
14 1Blank
01 5Allowed
02 5Approved
03 8Authorized
04 5DISCN
05 5Deregistered
06 2Generic
07 4Lead Market Dossiers- Filed
08 1Marketed
09 5Not Marketed
10 3Originator
11 9Prescription
12 20RX
13 4US FDA Preapproval Inspection- Pass
14 9Blank
01 6ARIXTRA
02 30Arixtra
03 5Arixtra
04 1Arixtra 10,0mg/0,8ml
05 1Arixtra 2,5 mg/0,5 ml
06 1Arixtra 5,0mg/0,4ml
07 1Arixtra 7,5mg/0,6ml
08 2Arixtra®
09 21FONDAPARINUX SODIUM
10 2FONDAPARINUX SODIUM INJECTION
11 1Product Under Development
12 5Quixidar
13 9Blank
01 1Australia
02 4Canada
03 4China
04 1Egypt
05 5Estonia
06 4India
07 5Italy
08 2Moldova
09 6Norway
10 4South Africa
11 8Spain
12 10Sweden
13 5Switzerland
14 25USA
15 1Ukraine
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 1,5Mg 0,3Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 1.5 mg 0.3 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ARIXTRA
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging : 0.5ML
Approval Date :
Application Number : 2245531
Regulatory Info : Prescription
Registration Country : Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2.5MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 10Mg 0,8Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 10 mg 0.8 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 2,5Mg 0,5Ml 10 Inita' Parenteral Use
Dosage Strength : 10 SYRINGES SC 2.5 mg 0.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 5Mg 0.4 Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 5 mg 0.4 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Italy
Brand Name : Arixtra
Dosage Form : Fondaparinux 7,5Mg 0,6Ml 10 Units Parenteral Use
Dosage Strength : 10 SYRINGES SC 7.5 mg 0.6 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ARIXTRA
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.6ML
Packaging : 0.6ML
Approval Date :
Application Number : 2258056
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Arixtra 2,5 mg/0,5 ml
Dosage Form : INJ
Dosage Strength : 2.5mg/0.5ml
Packaging : 0.5X10mg/0.5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Arixtra 5,0mg/0,4ml
Dosage Form : INJ
Dosage Strength : 5mg/0.4ml
Packaging : 0.4X10mg/0.4ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Arixtra 7,5mg/0,6ml
Dosage Form : INJ
Dosage Strength : 7.5mg/0.6ml
Packaging : 0.6X10mg/0.6ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Arixtra 10,0mg/0,8ml
Dosage Form : INJ
Dosage Strength : 10mg/0.8ml
Packaging : 0.8X10mg/0.8ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Arixtra
Dosage Form :
Dosage Strength :
Packaging : 2
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/0.4ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 7.5MG/0.6ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10MG/0.8ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : FONDAPARINUX SODIUM INJECTION
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging : 10 PRE-FILLED SYRINGES
Approval Date :
Application Number : 2406853
Regulatory Info : Prescription
Registration Country : Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : FONDAPARINUX SODIUM INJECTION
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.6ML
Packaging : 10 PRE-FILLED SYRINGES
Approval Date :
Application Number : 2406896
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : ARIXTRA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML
Packaging :
Approval Date : 2001-12-07
Application Number : 21345
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ARIXTRA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 5MG/0.4ML
Packaging :
Approval Date : 2004-05-28
Application Number : 21345
Regulatory Info : RX
Registration Country : USA
