Orange Book product · Generic (ANDA)
TACROLIMUS
TACROLIMUS
At a glance
Feb 12, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 12, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TACROLIMUS
Strength
EQ 5MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 217108
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TACROLIMUS
- 2018PROGRAFBrand (NDA)
NDA 210115 · ASTELLAS
- 2015ENVARSUS XRBrand (NDA)
NDA 206406 · VELOXIS PHARMS INC
- 2013ASTAGRAF XLBrand (NDA)
NDA 204096 · ASTELLAS
- 2000PROTOPICBrand (NDA)
NDA 050777 · LEO PHARMA AS
- 1998PROGRAFBrand (NDA)
NDA 050708 · ASTELLAS
- 1994PROGRAFBrand (NDA)
NDA 050709 · ASTELLAS
- 2024TACROLIMUSGeneric (ANDA)
ANDA 215012 · CHENGDU
- 2023TACROLIMUSGeneric (ANDA)
ANDA 212387 · ENCUBE
- 2023TACROLIMUSGeneric (ANDA)
ANDA 210393 · GLENMARK PHARMS LTD
- 2023TACROLIMUSGeneric (ANDA)
ANDA 210929 · HANGZHOU ZHONGMEI
- 2020TACROLIMUSGeneric (ANDA)
ANDA 203740 · ALKEM LABS LTD
- 2020TACROLIMUSGeneric (ANDA)
ANDA 212297 · BIOCON PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
