Orange Book product · Brand (NDA)
RAPAMUNE
SIROLIMUS
At a glance
Sep 15, 1999
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 1999
27 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
SIROLIMUS
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 021083
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.
- 2022HYFTORBrand (NDA)
NDA 213478 · NOBELPHARMA
- 2021FYARROBrand (NDA)
NDA 213312 · AADI
- 2010RAPAMUNEBrand (NDA)
NDA 021110 · 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.
