FDA.reportPublic FDA data

Application 210115

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROGRAFTACROLIMUSFOR SUSPENSION;ORALEQ 0.2MG BASE/PACKETYesNo
002PROGRAFTACROLIMUSFOR SUSPENSION;ORALEQ 1MG BASE/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1230PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent
0469-1330PrografTacrolimusAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75496SUPPL 2023-09-15
75478SUPPL 2023-09-15
72705SUPPL2022-11-25
72686SUPPL2022-11-23
72685SUPPL2022-11-23
71268SUPPL2022-06-13
68118SUPPL2021-07-19
68102SUPPL2021-07-16
65800SUPPL2020-12-31
65787SUPPL2020-12-31
59032SUPPL2019-06-12
56672SUPPL2018-12-07
56582ORIG2018-11-28
54352ORIG2018-05-29
54346ORIG2018-05-29