Orange Book product · Generic (ANDA)
TACROLIMUS
TACROLIMUS
At a glance
Jul 01, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 01, 2010
16 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TACROLIMUS
Strength
EQ 5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 090402
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TACROLIMUS
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- 2013ASTAGRAF XLBrand (NDA)
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- 2000PROTOPICBrand (NDA)
NDA 050777 · LEO PHARMA AS
- 1998PROGRAFBrand (NDA)
NDA 050708 · ASTELLAS
- 1994PROGRAFBrand (NDA)
NDA 050709 · ASTELLAS
- 2025TACROLIMUSGeneric (ANDA)
ANDA 217108 · NEXUS
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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
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.
