Viewing data from:

Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

PRUCALOPRIDE SUCCINATE

ANDA

Tentative Approval

PRUCALOPRIDE SUCCINATE | A219180 | MICRO LABS

API Supply Chain12 active DMFs

12 active API suppliers hold Drug Master Files for this ingredient.

SYMED LABS LTDPRUCALOPRIDE SUCCINATE

DMF 348622020

METROCHEM API PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 349702020

SHILPA PHARMA LIFESCIENCES LTDPRUCALOPRIDE SUCCINATE

DMF 350382020

SS PHARMA LLCPRUCALOPRIDE SUCCINATE

DMF 367652022

MEDICHEM MANUFACTURING (MALTA) LTDPRUCALOPRIDE SUCCINATE

DMF 371812022

MSN LABORATORIES PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 373012022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPRUCALOPRIDE SUCCINATE

DMF 375762022

ALEMBIC PHARMACEUTICALS LTDPRUCALOPRIDE SUCCINATE

DMF 379112023

TORRENT PHARMACEUTICALS LTDPRUCALOPRIDE SUCCINATE

DMF 380842023

SUN PHARMACEUTICAL INDUSTRIES LTDPRUCALOPRIDE SUCCINATE

DMF 388932023

ERYTHRO PHARMA PRIVATE LTDPRUCALOPRIDE SUCCINATE ACID INTERMIDIATE

DMF 391882024

APITORIA PHARMA PRIVATE LTDPRUCALOPRIDE SUCCINATE

DMF 408602025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — EQ 1MG BASE

▴

TABLET;ORAL | Approved: N/A

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

▾

TABLET;ORAL | Approved: N/A