Details for New Drug Application (NDA): 019617

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NDA 019617 describes PREPIDIL, which is a drug marketed by Pharmacia And Upjohn 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 are four drug master file entries 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:	Pharmacia And Upjohn
Ingredient:	dinoprostone
Patents:	0
Formulation / Manufacturing:	see details

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 and Upjohn Company LLC	0009-3359	0009-3359-01	1 SYRINGE in 1 CARTON (0009-3359-01) > 3 g in 1 SYRINGE
PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617	NDA	Pharmacia and Upjohn Company LLC	0009-3359	0009-3359-02	5 CARTON in 1 PACKAGE (0009-3359-02) > 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
Pharmacia And Upjohn	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	Start Trial	Start Trial
Pharmacia And Upjohn	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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