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FDA NDA · NDA020776

DAYPRO ALTA

Sponsor: PFIZER

APPLICATION
NDA020776
TYPE
NDA
ORIGINAL APPROVAL
2002-10-17
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DAYPRO ALTADiscontinued
OXAPROZIN POTASSIUM 600MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 13 · standard — Letter ↗AP
2022-11-09Labeling · Supplement 11 · standard — Label ↗AP
2021-04-28Labeling · Supplement 10 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 8 · standard — Label ↗AP
2016-05-09Labeling · Supplement 6 · standard — Label ↗AP
2007-07-05Labeling · Supplement 2 · standard — Letter ↗AP
2006-01-18Labeling · Supplement 1 · standard — Letter ↗AP
2002-10-17Type 2 - New Active Ingredient · Original · standard — Label ↗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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