← FDA DRUG APPROVALS

FDA NDA · NDA020414

PYRIDOSTIGMINE BROMIDE

Sponsor: US ARMY

APPLICATION
NDA020414
TYPE
NDA
ORIGINAL APPROVAL
2003-02-05
LATEST ACTION
2025-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PYRIDOSTIGMINE BROMIDEDiscontinued
PYRIDOSTIGMINE BROMIDE 30MG · TABLET · ORAL

Approval history

2025-09-26Labeling · Supplement 12 · standard — Label ↗AP
2024-10-04Manufacturing (CMC) · Supplement 11 — Label ↗AP
2015-12-23Manufacturing (CMC) · Supplement 4 · priority — Review ↗AP
2014-09-30Manufacturing (CMC) · Supplement 3 · priority — Review ↗AP
2014-01-03Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
2003-02-05Type 3 - New Dosage Form · Original · priority — Review ↗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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