Orange Book product · Brand (NDA)
PROTOPIC
TACROLIMUS
At a glance
Dec 08, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 08, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TACROLIMUS
Strength
0.03%
Dosage form
OINTMENT
Route
TOPICAL
TE code
AB
Application
NDA 050777
Product number
001
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
- 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
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.
