APPLICATION
NDA009830
TYPE
NDA
ORIGINAL APPROVAL
1955-10-02
LATEST ACTION
2001-07-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MESTINON · ReferencePrescription
PYRIDOSTIGMINE BROMIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
2001-07-26Labeling · Supplement 12 · standardAP
1999-12-07Manufacturing (CMC) · Supplement 13 · standardAP
1996-11-07Manufacturing (CMC) · Supplement 11 · standardAP
1995-10-27Manufacturing (CMC) · Supplement 9 · standardAP
1990-06-12Manufacturing (CMC) · Supplement 8 · standardAP
1985-05-31Manufacturing (CMC) · Supplement 7 · standardAP
1983-11-16Manufacturing (CMC) · Supplement 6 · standardAP
1980-10-08Manufacturing (CMC) · Supplement 4 · standardAP
1955-10-02Type 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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