Orange Book product · Brand (NDA)
RAPAMUNE
SIROLIMUS
At a glance
Jan 25, 2010
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2010
16 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SIROLIMUS
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021110
Product number
004
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.
- 2022HYFTORBrand (NDA)
NDA 213478 · NOBELPHARMA
- 2021FYARROBrand (NDA)
NDA 213312 · AADI
- 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
- 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.
