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Cisapride monohydrate - Generic Drug Details

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Cisapride monohydrate is the generic ingredient in two branded drugs marketed by Janssen Pharms and Janssen Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cisapride monohydrate.

Summary for Generic Name: cisapride monohydrate

Tradenames:2
Patents:0
Applicants:2
NDAs:3
Drug Master File Entries: see list1
Formulation / Manufacturing:see details

Clinical Trials for: cisapride monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
PROPULSID
cisapride monohydrate
SUSPENSION;ORAL020398-001Sep 15, 1995DISCNNo<disabled><disabled>
Janssen Pharms
PROPULSID
cisapride monohydrate
TABLET;ORAL020210-001Jul 29, 1993DISCNNo<disabled><disabled>
Janssen Pharma
PROPULSID QUICKSOLV
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767-001Nov 7, 1997DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: cisapride monohydrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma
PROPULSID QUICKSOLV
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767-001Nov 7, 19975,648,093<disabled>
Janssen Pharms
PROPULSID
cisapride monohydrate
SUSPENSION;ORAL020398-001Sep 15, 19954,962,115<disabled>
Janssen Pharms
PROPULSID
cisapride monohydrate
TABLET;ORAL020210-002Dec 23, 19934,962,115<disabled>
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