Orange Book product · Generic (ANDA)
LUBIPROSTONE
LUBIPROSTONE
Generic (ANDA)ANDA 214131TE ABRX ZYDUS PHARMS
At a glance
Mar 23, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2023
3 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
LUBIPROSTONE
Strength
8MCG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 214131
Product number
001
Marketing status
RX
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
- 2022LUBIPROSTONEGeneric (ANDA)
ANDA 201442 · PH HEALTH
- 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.
