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PROPULSID

NDA

CISAPRIDE MONOHYDRATE | N020210 | JANSSEN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

VASUDHA PHARMA CHEM LTDCISAPRIDE MONOHYDRATE USP

DMF 312302017

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

Products (2)

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#001 — EQ 10MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 29, 1993

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 23, 1993