APPLICATION
NDA050322
TYPE
NDA
ORIGINAL APPROVAL
1969-07-02
LATEST ACTION
1998-12-29
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
NEODECADRONDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE, NEOMYCIN SULFATE EQ 3.5MG BASE/ML · SOLUTION/DROPS · OPHTHALMIC
Approval history
1998-12-29Manufacturing (CMC) · Supplement 48AP
1998-08-31Manufacturing (CMC) · Supplement 47AP
1998-02-24Manufacturing (CMC) · Supplement 46AP
1997-12-23Manufacturing (CMC) · Supplement 45AP
1996-04-16Manufacturing (CMC) · Supplement 44AP
1995-09-29Labeling · Supplement 17AP
1995-09-29Labeling · Supplement 15AP
1995-09-29Labeling · Supplement 13AP
1995-09-29Labeling · Supplement 16AP
1995-09-29Labeling · Supplement 14AP
1995-05-05Manufacturing (CMC) · Supplement 42AP
1995-04-25Manufacturing (CMC) · Supplement 43AP
1987-12-15Manufacturing (CMC) · Supplement 12AP
1987-04-03Labeling · Supplement 11AP
1986-01-22Manufacturing (CMC) · Supplement 10AP
1985-10-30Manufacturing (CMC) · Supplement 9AP
1985-03-07Labeling · Supplement 8AP
1984-08-27Manufacturing (CMC) · Supplement 5AP
1984-06-27Labeling · Supplement 7AP
1984-02-02Manufacturing (CMC) · Supplement 4AP
1983-04-22Manufacturing (CMC) · Supplement 3AP
1983-02-25Manufacturing (CMC) · Supplement 2AP
1981-01-13Labeling · Supplement 41AP
1980-08-28Labeling · Supplement 40AP
1980-08-06Manufacturing (CMC) · Supplement 39AP
1980-03-27Manufacturing (CMC) · Supplement 38AP
1980-02-27Manufacturing (CMC) · Supplement 37AP
1978-03-28Manufacturing (CMC) · Supplement 36AP
1978-01-24Manufacturing (CMC) · Supplement 35AP
1977-05-16Labeling · Supplement 34AP
1977-04-18Labeling · Supplement 33AP
1977-04-12Labeling · Supplement 32AP
1976-03-15Manufacturing (CMC) · Supplement 31AP
1976-01-09Labeling · Supplement 30AP
1975-10-17Manufacturing (CMC) · Supplement 29AP
1975-07-08Manufacturing (CMC) · Supplement 28AP
1973-12-17Labeling · Supplement 27AP
1973-04-23Manufacturing (CMC) · Supplement 26AP
1972-09-13Labeling · Supplement 25AP
1972-07-18Manufacturing (CMC) · Supplement 24AP
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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