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Generated: November 16, 2018

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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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the pentosan polysulfate sodium profile page.
Summary for 020193
Applicant:Janssen Pharms
Ingredient:pentosan polysulfate sodium
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)
ELMIRON pentosan polysulfate sodium CAPSULE;ORAL 020193 NDA Cardinal Health 55154-0553 55154-0553-8 3300 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55154-0553-8)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 26, 1996TE:RLD:Yes

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