Tacrolimus Extended Release Oral Capsule

Brand(s)
Astagraf
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fujisawa Healthcare, Inc. (2015-06-16)
Oldest Current Product
2013-07-19
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\TACROLIMUS
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\TACROLIMUS
SPL Active
ORAL\CAPSULE, COATED, EXTENDED RELEASE\TACROLIMUS
SPL Moiety
ORAL\CAPSULE, COATED, EXTENDED RELEASE\TACROLIMUS ANHYDROUS

product(s) by strength(s)

24 hr tacrolimus 0.5 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690647AstagrafNDAFujisawa Healthcare, Inc.2013-07-19TACROLIMUSORALCAPSULE, COATED, EXTENDED RELEASENDA204096550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e

24 hr tacrolimus 1 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690677AstagrafNDAFujisawa Healthcare, Inc.2013-07-19TACROLIMUSORALCAPSULE, COATED, EXTENDED RELEASENDA204096550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e

24 hr tacrolimus 5 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690687AstagrafNDAFujisawa Healthcare, Inc.2013-07-19TACROLIMUSORALCAPSULE, COATED, EXTENDED RELEASENDA204096550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204096ASTAGRAF XLASTELLAS PHARMA US INC2013-07-19p6884433, METHOD OF ONCE A DAY ADMINISTRATION, SUBSTANCE
p8551522, SUBSTANCE
p6576259, METHOD OF ONCE A DAY ADMINISTRATION, SUBSTANCE
p6440458, SUBSTANCE
NEW DOSAGE FORM [2016-07-19]NDA204096_001, NDA204096_002, NDA204096_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204096_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2013-07-19ASTAGRAF XL
2NDA204096_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2013-07-19ASTAGRAF XL
3NDA204096_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULE, EXTENDED RELEASETrue2013-07-19ASTAGRAF XL

patent(s)

#idexpiration dateapplication(s)
1p6440458 (view patent)2019-03-25NDA204096
2p6576259 (view patent)2019-03-25NDA204096
3p6884433 (view patent)2019-03-25NDA204096
4p8551522 (view patent)2019-03-25NDA204096

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e (view SPL)These highlights do not include all the information needed to use ASTAGRAF XL safely and effectively. See full prescribing information for ASTAGRAF XL. ASTAGRAF XL(tacrolimus extended-release capsules), for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionFujisawa Healthcare, Inc.ANALYSIS, MANUFACTURE2015-06-164004690647, 004690677, 004690687

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII