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FDA NDA · NDA050813

MOXATAG

Sponsor: PRAGMA

APPLICATION
NDA050813
TYPE
NDA
ORIGINAL APPROVAL
2008-01-23
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MOXATAG · ReferenceDiscontinued
AMOXICILLIN 775MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-05-01Labeling · Supplement 10 · standard — Letter ↗AP
2022-05-17Labeling · Supplement 9 · standard — Letter ↗AP
2019-11-06Labeling · Supplement 8 · standard — Letter ↗AP
2015-06-09Labeling · Supplement 3 · standard — Letter ↗AP
2008-01-23Type 3 - New Dosage Form · 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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