FDA.reportPublic FDA data

Application 020541

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIMIDEXANASTROZOLETABLET;ORAL1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0201ARIMIDEXAnastrozoleAstraZeneca Pharmaceuticals LPNDACurrent
62559-670ARIMIDEXAnastrozoleANI Pharmaceuticals, Inc.NDACurrent
62559-670ARIMIDEXAnastrozoleANI Pharmaceuticals, Inc.NDACurrent
62559-670ARIMIDEXAnastrozoleANI Pharmaceuticals, Inc.NDACurrent
62559-670ARIMIDEXAnastrozoleANI Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80620SUPPL 2024-12-18
80603SUPPL 2024-12-17
63853ORIG2020-01-01
57660ORIG2019-02-15
57144SUPPL2019-01-09
56877SUPPL2018-12-20
54293SUPPL2018-05-22
54292SUPPL2018-05-22
54291SUPPL2018-05-22
53731SUPPL2018-04-18
12705SUPPL2014-05-06
2698SUPPL2014-05-06
12704SUPPL2013-05-09
2697SUPPL2013-05-07
25144SUPPL2011-04-20
34805SUPPL2011-04-18
12703SUPPL2009-05-11
12702SUPPL2009-05-11
25143SUPPL2009-05-06
2696SUPPL2009-05-06
34804SUPPL2009-01-02
34803SUPPL2009-01-02
12701SUPPL2009-01-02
25142SUPPL2008-12-18
25141SUPPL2008-12-18
12700SUPPL2005-09-22
2695SUPPL2005-09-22
34802SUPPL2004-09-03
2694SUPPL2004-09-03
41419SUPPL2004-05-27
41420SUPPL2003-07-08
25139SUPPL2002-10-07
25140SUPPL2002-09-05
12699SUPPL2002-09-05
12698SUPPL2000-09-01
2693SUPPL2000-09-01