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FDA ANDA · ANDA040512

PYRIDOSTIGMINE BROMIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA040512
TYPE
ANDA
ORIGINAL APPROVAL
2003-10-08
LATEST ACTION
2005-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

PYRIDOSTIGMINE BROMIDEPrescription
PYRIDOSTIGMINE BROMIDE 60MG · TABLET · ORAL
PYRIDOSTIGMINE BROMIDEDiscontinued
PYRIDOSTIGMINE BROMIDE 30MG · TABLET · ORAL

Approval history

2005-07-20Labeling · Supplement 3AP
2003-10-08OriginalReviewAP
VIEW ON DRUGS@FDA ↗

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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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