APPLICATION
NDA009829
TYPE
NDA
ORIGINAL APPROVAL
1955-04-06
LATEST ACTION
2014-05-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MESTINON · ReferencePrescription
PYRIDOSTIGMINE BROMIDE 60MG · TABLET · ORAL
Approval history
2014-05-16Manufacturing (CMC) · Supplement 17 · standardAP
2014-01-09Manufacturing (CMC) · Supplement 16 · standardAP
2001-07-26Labeling · Supplement 11 · standardAP
2000-07-20Manufacturing (CMC) · Supplement 15 · standardAP
1999-09-30Manufacturing (CMC) · Supplement 14 · standardAP
1997-11-10Manufacturing (CMC) · Supplement 13 · standardAP
1996-11-07Manufacturing (CMC) · Supplement 12 · standardAP
1995-10-24Manufacturing (CMC) · Supplement 10 · standardAP
1986-01-27Labeling · Supplement 7AP
1981-02-18Manufacturing (CMC) · Supplement 5 · standardAP
1955-04-06Type 1 - New Molecular Entity · Original · standardAP
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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