Orange Book product · Brand (NDA)
PROGRAF
TACROLIMUS
At a glance
May 24, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 2018
8 yr 2 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 0.2MG BASE/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 210115
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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
- 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.
