Orange Book product · Generic (ANDA)
LUBIPROSTONE
LUBIPROSTONE
At a glance
Jun 27, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 27, 2022
4 yr ago
Today
Pharmaceutical detail
Active ingredient
LUBIPROSTONE
Strength
8MCG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 201442
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LUBIPROSTONE
- 2008AMITIZABrand (NDA)
NDA 021908 · SUCAMPO PHARMA LLC
- 2025LUBIPROSTONEGeneric (ANDA)
ANDA 218640 · ASCENT PHARMS INC
- 2023LUBIPROSTONEGeneric (ANDA)
ANDA 214131 · ZYDUS PHARMS
- 2022LUBIPROSTONEGeneric (ANDA)
ANDA 206994 · DR REDDYS
- 2022LUBIPROSTONEGeneric (ANDA)
ANDA 209920 · TEVA PHARMS USA INC
- 2021LUBIPROSTONEGeneric (ANDA)
ANDA 209450 · 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.
