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FDA NDA · NDA020193

ELMIRON

pentosan polysulfate sodium

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020193
TYPE
NDA
ORIGINAL APPROVAL
1996-09-26
LATEST ACTION
2021-03-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ELMIRON · ReferencePrescription
PENTOSAN POLYSULFATE SODIUM 100MG · CAPSULE · ORAL

Approval history

2021-03-12Labeling · Supplement 15 · standard — Label ↗AP
2020-06-16Labeling · Supplement 14 · standard — Letter ↗AP
2008-12-12Labeling · Supplement 9 · standard — Label ↗AP
2008-07-24Labeling · Supplement 7 · standard — Label ↗AP
2006-09-20Labeling · Supplement 4 · standard — Letter ↗AP
2004-08-24Labeling · Supplement 3 · standard — Letter ↗AP
2001-11-08Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1996-09-26Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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