FDA NDA · NDA015193

PYRIDOSTIGMINE BROMIDE

Sponsor: BAUSCH

APPLICATION

NDA015193

TYPE

NDA

ORIGINAL APPROVAL

1965-01-25

LATEST ACTION

2019-10-29

ROUTE

ORAL

DOSAGE FORM

SYRUP

MARKETING STATUS

Prescription

Products

MESTINON · ReferencePrescription

PYRIDOSTIGMINE BROMIDE 60MG/5ML · SYRUP · ORAL

2019-10-29Labeling · Supplement 27 · standard — Letter ↗AP

2015-02-23Manufacturing (CMC) · Supplement 25 · standardAP

2014-09-30Manufacturing (CMC) · Supplement 23 · standardAP

2013-09-26Manufacturing (CMC) · Supplement 24 · standardAP

2002-05-22Manufacturing (CMC) · Supplement 20 · standard — Letter ↗AP

2001-07-26Labeling · Supplement 18 · standard — Label ↗AP

1996-11-07Manufacturing (CMC) · Supplement 19 · standardAP

1995-10-27Manufacturing (CMC) · Supplement 17 · standardAP

1993-06-17Manufacturing (CMC) · Supplement 16 · standardAP

1986-01-27Labeling · Supplement 14AP

1982-02-04Manufacturing (CMC) · Supplement 12 · standardAP

1965-01-25Type 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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