Orange Book product · Generic (ANDA)
SIROLIMUS
SIROLIMUS
At a glance
Jan 19, 2023
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 19, 2023
3 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
SIROLIMUS
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 216728
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
- 2025SIROLIMUSGeneric (ANDA)
ANDA 215116 · RISING
- 2024SIROLIMUSGeneric (ANDA)
ANDA 215080 · HETERO LABS LTD V
- 2023SIROLIMUSGeneric (ANDA)
ANDA 201676 · ZYDUS PHARMS
- 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.
