Orange Book product · Brand (NDA)
ACTIGALL
URSODIOL
At a glance
Dec 31, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1987
39 yr ago
Today
Pharmaceutical detail
Active ingredient
URSODIOL
Strength
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 019594
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1997URSO 250Brand (NDA)
NDA 020675 · ABBVIE
- 2026URSODIOLGeneric (ANDA)
ANDA 210344 · STRIDES PHARMA
- 2024URSODIOLGeneric (ANDA)
ANDA 214717 · EPIC PHARMA LLC
- 2022URSODIOLGeneric (ANDA)
ANDA 214849 · AUROBINDO PHARMA LTD
- 2021URSODIOLGeneric (ANDA)
ANDA 214329 · RK PHARMA
- 2020URSODIOLGeneric (ANDA)
ANDA 214295 · ZYDUS LIFESCIENCES
- 2020URSODIOLGeneric (ANDA)
ANDA 213504 · STRIDES PHARMA
- 2020URSODIOLGeneric (ANDA)
ANDA 213555 · CHARTWELL RX
- 2020URSODIOLGeneric (ANDA)
ANDA 205789 · LGM PHARMA
- 2020URSODIOLGeneric (ANDA)
ANDA 213200 · RISING
- 2019URSODIOLGeneric (ANDA)
ANDA 212452 · HIBROW HLTHCARE
- 2018URSODIOLGeneric (ANDA)
ANDA 211145 · ZYDUS LIFESCIENCES
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.
