FDA.reportPublic FDA data

Application 021264

Type
NDA
Sponsor
US WORLDMEDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APOKYNAPOMORPHINE HYDROCHLORIDEINJECTABLE;SUBCUTANEOUS20MG/2ML (10MG/ML)NoNo
002APOKYNAPOMORPHINE HYDROCHLORIDEINJECTABLE;SUBCUTANEOUS30MG/3ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEUS WorldMeds, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEUS WorldMeds, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEUS WorldMeds, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEMDD US Operations, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEUS WorldMeds, LLCNDACurrent
27505-004APOKYNAPOMORPHINE HYDROCHLORIDEUS WorldMeds, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81127SUPPL 2025-02-07
81059SUPPL 2025-02-06
71448SUPPL2022-06-24
71431SUPPL2022-06-23
71023SUPPL2022-05-06
71008SUPPL2022-05-06
62818SUPPL2020-05-05
62810SUPPL2020-05-04
61969SUPPL2020-02-26
61141SUPPL2019-12-04
58825SUPPL2019-05-22
58803SUPPL2019-05-21
47589SUPPL2017-03-20
47582SUPPL2017-03-17
14781SUPPL2014-07-28
4824SUPPL2014-07-28
36503SUPPL2010-09-07
27263SUPPL2010-09-07
27262SUPPL2009-01-06
27261SUPPL2009-01-06
21554ORIG2004-08-27
36502ORIG2004-05-04
27260ORIG2004-04-29