Last Updated: September 24, 2026

Details for New Drug Application (NDA): 019617

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NDA 019617 describes PREPIDIL, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the PREPIDIL profile page.

The generic ingredient in PREPIDIL is dinoprostone. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dinoprostone profile page.

Summary for 019617

Tradename:	PREPIDIL
Applicant:	Pfizer
Ingredient:	dinoprostone
Patents:	0

Pharmacology for NDA: 019617

Medical Subject Heading (MeSH) Categories for 019617

Oxytocics

Suppliers and Packaging for NDA: 019617

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617	NDA	Pharmacia & Upjohn Company LLC	0009-3359	0009-3359-01	1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;ENDOCERVICAL			Strength	0.5MG/3GM
Approval Date:	Dec 9, 1992	TE:		RLD:	Yes

Expired US Patents for NDA 019617

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	3,966,962	⤷ Start Trial
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	4,680,312	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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