FDA.reportPublic FDA data

Application 204096

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASTAGRAF XLTACROLIMUSCAPSULE, EXTENDED RELEASE;ORALEQ 0.5MG BASEYesNo
002ASTAGRAF XLTACROLIMUSCAPSULE, EXTENDED RELEASE;ORALEQ 1MG BASEYesNo
003ASTAGRAF XLTACROLIMUSCAPSULE, EXTENDED RELEASE;ORALEQ 5MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-0647ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0647ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0647ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0647ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0647ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0677ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0677ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0677ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0677ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0677ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0687ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0687ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0687ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0687ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent
0469-0687ASTAGRAF XLtacrolimus extended-release capsulesAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75494SUPPL 2023-09-15
75493SUPPL 2023-09-15
75472SUPPL 2023-09-15
72706SUPPL2022-11-25
72692SUPPL2022-11-23
72691SUPPL2022-11-23
65797SUPPL2020-12-31
65796SUPPL2020-12-31
65783SUPPL2020-12-31
59034SUPPL2019-06-12
59033SUPPL2019-06-12
59029SUPPL2019-06-12
56823SUPPL2018-12-20
56598SUPPL2018-11-30
32510SUPPL2015-12-18
10296SUPPL2015-12-18
40354SUPPL2015-12-17
19527SUPPL2015-12-17
22943ORIG2014-12-18
44895ORIG2014-11-17
40353SUPPL2014-03-04
10295SUPPL2014-03-04
10294SUPPL2014-02-12
32509ORIG2013-07-26
19526ORIG2013-07-23