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FDA NDA · NDA217604

PYRIDOSTIGMINE BROMIDE

Sponsor: AMNEAL

APPLICATION
NDA217604
TYPE
NDA
ORIGINAL APPROVAL
2024-10-04
LATEST ACTION
2026-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PYRIDOSTIGMINE BROMIDEDiscontinued
PYRIDOSTIGMINE BROMIDE 105MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-05-12Labeling · Supplement 6 · standard — Letter ↗AP
2024-10-04Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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