FDA.reportPublic FDA data

Application 021345

Type
NDA
Sponsor
MYLAN IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIXTRAFONDAPARINUX SODIUMINJECTABLE;SUBCUTANEOUS2.5MG/0.5MLYesYes
002ARIXTRAFONDAPARINUX SODIUMINJECTABLE;SUBCUTANEOUS5MG/0.4MLYesYes
003ARIXTRAFONDAPARINUX SODIUMINJECTABLE;SUBCUTANEOUS7.5MG/0.6MLYesYes
004ARIXTRAFONDAPARINUX SODIUMINJECTABLE;SUBCUTANEOUS10MG/0.8MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-582Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-582Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-582Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-583Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-583Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-583Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-584Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-584Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-584Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-585Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-585Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-585Fondaparinux Sodiumfondaparinux sodiumMylan Institutional LLCNDA AUTHORIZED GENERICCurrent
67457-592Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-592Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-592Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-592Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-592Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-592Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-593Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-593Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-593Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-593Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-593Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-593Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-594Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-594Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-594Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-594Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-594Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-594Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-595Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-595Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-595Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-595Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-595Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent
67457-595Arixtrafondaparinux sodiumMylan Institutional LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80806SUPPL 2025-01-02
80753SUPPL 2024-12-27
64554SUPPL2020-09-11
64416SUPPL2020-08-26
61301SUPPL2019-12-17
61280SUPPL2019-12-16
49485SUPPL2017-08-21
49461SUPPL2017-08-18
36710SUPPL2014-07-17
5108SUPPL2014-07-17
36709SUPPL2013-09-17
5107SUPPL2013-09-13
15239SUPPL2010-04-04
27541SUPPL2010-03-31
27542SUPPL2009-12-31
15240SUPPL2009-12-30
27540SUPPL2009-11-25
15238SUPPL2009-09-18
27539SUPPL2008-10-21
36708SUPPL2005-05-27
5106SUPPL2005-05-27
27538SUPPL2004-06-01
15237SUPPL2004-06-01
15236SUPPL2004-06-01
5105SUPPL2004-06-01
42114ORIG2004-05-27
27537SUPPL2003-06-22
15235SUPPL2003-06-22
27536SUPPL2002-12-04
15234SUPPL2002-12-04
15233ORIG2001-12-07
5104ORIG2001-12-07