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ELMIRON

NDA · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 1996-09-26

Drug application

FDA Application #

NDA020193

Application type

New Drug Application

Brand name

ELMIRON

Generic name

PENTOSAN POLYSULFATE SODIUM

Active ingredients

PENTOSAN POLYSULFATE SODIUM

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN PHARMS

Manufacturer

Janssen Pharmaceuticals, Inc.

First approval

1996-09-26

Source

Authoritative

Drugs@FDA application overview

Machine

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