Details for New Drug Application (NDA): 020411

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NDA 020411 describes CERVIDIL, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CERVIDIL profile page.

The generic ingredient in CERVIDIL 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 020411

Tradename:	CERVIDIL
Applicant:	Ferring Pharms Inc
Ingredient:	dinoprostone
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020411

Ingredient-type	Prostaglandins

Medical Subject Heading (MeSH) Categories for 020411

Oxytocics

Suppliers and Packaging for NDA: 020411

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411	NDA	Ferring Pharmaceuticals Inc.	55566-2800	55566-2800-1	1 POUCH in 1 CARTON (55566-2800-1) > 10 mg in 1 POUCH (55566-2800-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT, EXTENDED RELEASE;VAGINAL			Strength	10MG
Approval Date:	Mar 30, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020411

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	➤ Sign Up	➤ Sign Up
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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