Orange Book product · Brand (NDA)
CIALIS
TADALAFIL
At a glance
Jan 07, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 07, 2008
18 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
TADALAFIL
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021368
Product number
004
Marketing status
DISCN
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.
- 2024CHEWTADZYBrand (NDA)
NDA 218527 · B BETTER
- 2022TADLIQBrand (NDA)
NDA 214522 · CMP DEV LLC
- 2009ADCIRCABrand (NDA)
NDA 022332 · ELI LILLY CO
- 2026TADALAFILGeneric (ANDA)
ANDA 210329 · JUBILANT GENERICS
- 2024TADALAFILGeneric (ANDA)
ANDA 216279 · SHANDONG
- 2024TADALAFILGeneric (ANDA)
ANDA 217606 · FOURRTS LABS
- 2023TADALAFILGeneric (ANDA)
ANDA 212515 · ZYDUS PHARMS
- 2023TADALAFILGeneric (ANDA)
ANDA 215949 · NOVITIUM PHARMA
- 2022ALYQGeneric (ANDA)
ANDA 216932 · TEVA PHARMS INC
- 2022TADALAFILGeneric (ANDA)
ANDA 210609 · PRINSTON INC
- 2022TADALAFILGeneric (ANDA)
ANDA 210608 · PRINSTON INC
- 2021TADALAFILGeneric (ANDA)
ANDA 215556 · VKT PHARMA
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.
