Tacrolimus Extended Release Oral Tablet

Brand(s)
Envarsus
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Veloxis Pharmaceuticals, Inc (2015-08-19)
Oldest Current Product
2015-09-01
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\TACROLIMUS
FDAOB
ORAL\TABLET, EXTENDED RELEASE\TACROLIMUS
SPL Active
ORAL\TABLET, EXTENDED RELEASE\TACROLIMUS
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\TACROLIMUS ANHYDROUS

product(s) by strength(s)

24 hr tacrolimus 0.75 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1689923075EnvarsusNDAVeloxis Pharmaceuticals, Inc2015-09-01TACROLIMUSORALTABLET, EXTENDED RELEASENDA206406de2315b0-6344-43ac-9aea-3e3b68d828e7

24 hr tacrolimus 1 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1689923010EnvarsusNDAVeloxis Pharmaceuticals, Inc2015-09-01TACROLIMUSORALTABLET, EXTENDED RELEASENDA206406de2315b0-6344-43ac-9aea-3e3b68d828e7

24 hr tacrolimus 4 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1689923040EnvarsusNDAVeloxis Pharmaceuticals, Inc2015-09-01TACROLIMUSORALTABLET, EXTENDED RELEASENDA206406de2315b0-6344-43ac-9aea-3e3b68d828e7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206406ENVARSUS XRVELOXIS PHARMACEUTICALS INC2015-07-10p8617599, SUBSTANCE
p8685998, PROPHYLAXIS OF ORGAN REJECTION, SUBSTANCE
p7994214, SUBSTANCE
p8586084, PROPHYLAXIS OF ORGAN REJECTION
p8591946, SUBSTANCE
p8486993, PROPHYLAXIS OF ORGAN REJECTION, SUBSTANCE
p8889185, PROPHYLAXIS OF ORGAN REJECTION
p8889186, PROPHYLAXIS OF ORGAN REJECTION
p8664239, PROPHYLAXIS OF ORGAN REJECTION
p8623410, SUBSTANCE
p8623411, PROPHYLAXIS OF ORGAN REJECTION
ORPHAN DRUG EXCLUSIVITY [2022-07-10]NDA206406_001, NDA206406_002, NDA206406_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206406_001RXTACROLIMUS (EQ 0.75MG BASE)ORALTABLET, EXTENDED RELEASEFalse2015-07-10ENVARSUS XR
2NDA206406_002RXTACROLIMUS (EQ 1MG BASE)ORALTABLET, EXTENDED RELEASEFalse2015-07-10ENVARSUS XR
3NDA206406_003RXTACROLIMUS (EQ 4MG BASE)ORALTABLET, EXTENDED RELEASETrue2015-07-10ENVARSUS XR

patent(s)

#idexpiration dateapplication(s)
1p7994214 (view patent)2024-08-30NDA206406
2p8486993 (view patent)2024-08-30NDA206406
3p8586084 (view patent)2024-08-30NDA206406
4p8591946 (view patent)2024-08-30NDA206406
5p8617599 (view patent)2024-08-30NDA206406
6p8623410 (view patent)2024-08-30NDA206406
7p8623411 (view patent)2024-08-30NDA206406
8p8664239 (view patent)2028-05-30NDA206406
9p8685998 (view patent)2028-05-30NDA206406
10p8889185 (view patent)2024-08-30NDA206406
11p8889186 (view patent)2024-08-30NDA206406

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1de2315b0-6344-43ac-9aea-3e3b68d828e7 (view SPL)These highlights do not include all the information needed to use ENVARSUS XR safely and effectively. See full prescribing information for ENVARSUS XR. ENVARSUS XR (tacrolimus extended-release tablets), for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionVeloxis Pharmaceuticals, IncMANUFACTURE2015-08-193689923010, 689923040, 689923075

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