APPLICATION
NDA011860
TYPE
NDA
ORIGINAL APPROVAL
1959-08-05
LATEST ACTION
1998-05-29
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
HUMORSOLDiscontinued
DEMECARIUM BROMIDE 0.25% · SOLUTION/DROPS · OPHTHALMIC
HUMORSOLDiscontinued
DEMECARIUM BROMIDE 0.125% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1998-05-29Manufacturing (CMC) · Supplement 30 · standardAP
1998-04-15Manufacturing (CMC) · Supplement 31 · standardAP
1997-03-04Manufacturing (CMC) · Supplement 29 · standardAP
1997-02-20Manufacturing (CMC) · Supplement 28 · standardAP
1997-01-30Manufacturing (CMC) · Supplement 27 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 26 · standardAP
1995-04-25Manufacturing (CMC) · Supplement 25 · standardAP
1993-12-22Labeling · Supplement 24 · standardAP
1991-04-23Labeling · Supplement 23 · standardAP
1988-01-13Manufacturing (CMC) · Supplement 22 · standardAP
1987-05-06Labeling · Supplement 14 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 20 · standardAP
1986-02-12Manufacturing (CMC) · Supplement 19 · standardAP
1984-12-06Manufacturing (CMC) · Supplement 18 · standardAP
1984-06-14Manufacturing (CMC) · Supplement 17 · standardAP
1981-10-27Manufacturing (CMC) · Supplement 16 · standardAP
1981-10-13Manufacturing (CMC) · Supplement 15 · standardAP
1981-07-15Manufacturing (CMC) · Supplement 13 · standardAP
1979-12-21Manufacturing (CMC) · Supplement 12 · standardAP
1978-07-05Labeling · Supplement 11 · standardAP
1978-06-22Labeling · Supplement 8 · standardAP
1976-04-21Manufacturing (CMC) · Supplement 10 · standardAP
1959-08-05Type 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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