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FDA NDA · NDA050783

PERIOSTAT

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APPLICATION
NDA050783
TYPE
NDA
ORIGINAL APPROVAL
2001-02-02
LATEST ACTION
2025-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERIOSTAT · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-04-01Labeling · Supplement 5 · standard — Label ↗AP
2004-03-31Labeling · Supplement 2 · standard — Letter ↗AP
2001-07-19Manufacturing (CMC) · Supplement 1 · standardAP
2001-02-02Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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