Details for New Drug Application (NDA): 020193

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NDA 020193 describes ELMIRON, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ELMIRON profile page.

The generic ingredient in ELMIRON is pentosan polysulfate sodium. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pentosan polysulfate sodium profile page.

Summary for 020193

Tradename:	ELMIRON
Applicant:	Janssen Pharms
Ingredient:	pentosan polysulfate sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020193

Suppliers and Packaging for NDA: 020193

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193	NDA	Janssen Pharmaceuticals, Inc.	50458-098	50458-098-01	100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Sep 26, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020193

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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