Orange Book product · Generic (ANDA)
SIROLIMUS
SIROLIMUS
At a glance
Jul 15, 2025
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 15, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
SIROLIMUS
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 215116
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SIROLIMUS
- 2022HYFTORBrand (NDA)
NDA 213478 · NOBELPHARMA
- 2021FYARROBrand (NDA)
NDA 213312 · AADI
- 2010RAPAMUNEBrand (NDA)
NDA 021110 · PF PRISM CV
- 1999RAPAMUNEBrand (NDA)
NDA 021083 · PF PRISM CV
- 2024SIROLIMUSGeneric (ANDA)
ANDA 215080 · HETERO LABS LTD V
- 2023SIROLIMUSGeneric (ANDA)
ANDA 201676 · ZYDUS PHARMS
- 2023SIROLIMUSGeneric (ANDA)
ANDA 216728 · MSN
- 2021SIROLIMUSGeneric (ANDA)
ANDA 215016 · TORRENT
- 2021SIROLIMUSGeneric (ANDA)
ANDA 214753 · ALKEM LABS LTD
- 2020SIROLIMUSGeneric (ANDA)
ANDA 208691 · GLENMARK PHARMS LTD
- 2019SIROLIMUSGeneric (ANDA)
ANDA 211406 · APOTEX
- 2019SIROLIMUSGeneric (ANDA)
ANDA 211212 · AMNEAL
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.
