FDA.reportPublic FDA data

Application 050708

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROGRAFTACROLIMUSCAPSULE;ORALEQ 1MG BASEYesNo
002PROGRAFTACROLIMUSCAPSULE;ORALEQ 5MG BASEYesYes
003PROGRAFTACROLIMUSCAPSULE;ORALEQ 0.5MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0607PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0617PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-0657PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
21695-170PrografTacrolimusRebel Distributors CorpNDACurrent
43353-178PrografTacrolimusAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75495SUPPL 2023-09-15
75477SUPPL 2023-09-15
72703SUPPL2022-11-25
72688SUPPL2022-11-23
72687SUPPL2022-11-23
71266SUPPL2022-06-13
68116SUPPL2021-07-19
68100SUPPL2021-07-16
65798SUPPL2020-12-31
65784SUPPL2020-12-31
59030SUPPL2019-06-12
56673SUPPL2018-12-07
56629SUPPL2018-12-04
54353SUPPL2018-05-29
54347SUPPL2018-05-29
30313SUPPL2015-05-21
18060SUPPL2015-05-21
30312SUPPL2013-09-09
18059SUPPL2013-09-09
44516SUPPL2012-10-11
42684SUPPL2012-10-11
18058SUPPL2012-08-15
8053SUPPL2012-08-15
18057SUPPL2012-07-10
30311SUPPL2012-07-09
8052SUPPL2012-02-08
39146SUPPL2012-02-06
30310SUPPL2011-07-19
8051SUPPL2011-07-19
18056SUPPL2011-07-18
18055SUPPL2011-07-18
8050SUPPL2009-05-27
18053SUPPL2009-05-21
18054SUPPL2009-02-20
30309SUPPL2009-02-18
18052SUPPL2006-05-01
8049SUPPL2006-05-01
8047SUPPL2006-04-05
8048SUPPL2005-12-16
39145SUPPL2004-06-23
8046SUPPL2004-06-23
39142SUPPL2004-06-14
42683ORIG2003-09-10
39144SUPPL2003-05-02
39143SUPPL2003-05-02
18051SUPPL2003-05-02