Orange Book product · Brand (NDA)
PROGRAF
TACROLIMUS
At a glance
Apr 08, 1994
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 1994
32 yr 8 mo ago
Today
Exclusivity ends · ODE-360
Orphan-drug exclusivity (7 years)
Jul 16, 2028
in 2 yr 1 mo
Pharmaceutical detail
Active ingredient
TACROLIMUS
Strength
EQ 5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 050708
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 1994PROGRAFBrand (NDA)
NDA 050709 · ASTELLAS
- 2025TACROLIMUSGeneric (ANDA)
ANDA 217108 · NEXUS
- 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
Marketing exclusivity (1)
- ODE-360Orphan-drug exclusivity (7 years)
Jul 16, 2028
in 2 yr 1 mo
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.
