FDA.reportPublic FDA data

Application 020498

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CASODEXBICALUTAMIDETABLET;ORAL50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0705CASODEXBicalutamideAstraZeneca Pharmaceuticals LPNDACurrent
62559-680CASODEXBicalutamideANI Pharmaceuticals, Inc.NDACurrent
62559-680CASODEXBicalutamideANI Pharmaceuticals, Inc.NDACurrent
62559-890BicalutamideBicalutamideANI Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57654ORIG2019-02-15
50647SUPPL2017-12-08
50299SUPPL2017-11-06
47658SUPPL2017-03-23
47588SUPPL2017-03-20
34716SUPPL2015-03-04
25053SUPPL2015-03-02
34715SUPPL2010-09-20
2606SUPPL2010-09-20
25052SUPPL2009-03-16
2605SUPPL2009-03-16
34714SUPPL2009-02-12
12641SUPPL2009-02-12
25051SUPPL2006-03-23
12640SUPPL2006-03-14
25050SUPPL2005-05-17
12639SUPPL2005-05-17
66496ORIG1900-01-01
66494ORIG1900-01-01
66492ORIG1900-01-01
63872ORIG1900-01-01
63871ORIG1900-01-01
63870ORIG1900-01-01
63869ORIG1900-01-01
63868ORIG1900-01-01
63867ORIG1900-01-01