FDA.reportPublic FDA data

Application 021324

Type
NDA
Sponsor
PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENTOCORT ECBUDESONIDECAPSULE;ORAL3MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-9850Entocort ECBudesonidePaddock Laboratories, LLCNDACurrent
0574-9850Entocort ECBudesonidePaddock Laboratories, LLCNDACurrent
0574-9850Entocort ECBudesonidePadagis US LLCNDACurrent
0574-9850Entocort ECBudesonidePaddock Laboratories, LLCNDACurrent
0574-9855budesonidebudesonidePadagis US LLCNDACurrent
0574-9855budesonidebudesonidePadagis US LLCNDACurrent
0574-9855budesonidebudesonidePaddock Laboratories, LLC.NDACurrent
0574-9855budesonidebudesonidePaddock Laboratories, LLCNDACurrent
0574-9855budesonidebudesonidePaddock Laboratories, LLCNDACurrent
65483-702ENTOCORTBudesonidePrometheus Laboratories IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78718SUPPL 2024-06-07
78660SUPPL 2024-06-06
63955SUPPL2020-07-17
63920SUPPL2020-07-15
57301SUPPL2019-01-22
57290SUPPL2019-01-22
62322SUPPL2019-01-18
50108SUPPL2017-10-19
50098SUPPL2017-10-19
36666SUPPL2016-05-03
27492SUPPL2016-05-03
15197SUPPL2016-05-03
5048SUPPL2016-05-03
15196SUPPL2011-12-23
27491SUPPL2011-12-22
15195SUPPL2009-06-24
5047SUPPL2009-06-24
62321SUPPL2009-06-22
36665SUPPL2005-05-03
5046SUPPL2005-05-03
27490SUPPL2004-06-03
5044SUPPL2004-06-03
23071ORIG2003-05-07
5045SUPPL2003-03-26
36664ORIG2001-10-02
27489ORIG2001-10-02
21601ORIG2001-10-02
52053ORIG1900-01-01
52051SUPPL1900-01-01
52050ORIG1900-01-01