Orange Book product · Generic (ANDA)
PRUCALOPRIDE SUCCINATE
PRUCALOPRIDE SUCCINATE
At a glance
Jun 24, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 24, 2025
1 yr ago
Today
Pharmaceutical detail
Active ingredient
PRUCALOPRIDE SUCCINATE
Strength
EQ 1MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 219078
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PRUCALOPRIDE SUCCINATE
- 2018MOTEGRITYBrand (NDA)
NDA 210166 · TAKEDA PHARMS USA
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ANDA 219071 · TEVA PHARMS INC
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ANDA 219220 · AJANTA PHARMA LTD
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ANDA 218056 · ZYDUS LIFESCIENCES
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ANDA 218295 · ALKEM LABS LTD
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 218812 · AMNEAL
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 219160 · ANNORA PHARMA
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 218977 · APOTEX
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 218963 · APPCO
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 219216 · H2-PHARMA
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 217662 · HIKMA
- 2025PRUCALOPRIDE SUCCINATEGeneric (ANDA)
ANDA 218847 · LUPIN
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.
