APPLICATION
NDA011665
TYPE
NDA
ORIGINAL APPROVAL
1959-01-12
LATEST ACTION
2014-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MESTINON · ReferencePrescription
PYRIDOSTIGMINE BROMIDE 180MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2014-07-25Manufacturing (CMC) · Supplement 20 · standardAP
2014-01-03Manufacturing (CMC) · Supplement 19 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 18 · standardAP
2001-07-26Labeling · Supplement 13 · standardAP
2001-02-13Manufacturing (CMC) · Supplement 17 · standardAP
1996-11-07Manufacturing (CMC) · Supplement 16 · standardAP
1995-10-24Manufacturing (CMC) · Supplement 14 · standardAP
1989-07-18Manufacturing (CMC) · Supplement 11 · standardAP
1986-01-27Labeling · Supplement 10AP
1978-11-22Manufacturing (CMC) · Supplement 8 · standardAP
1978-02-16Manufacturing (CMC) · Supplement 7 · standardAP
1977-02-09Manufacturing (CMC) · Supplement 5 · standardAP
1959-01-12Type 3 - New Dosage Form · 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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