APPLICATION
NDA011984
TYPE
NDA
ORIGINAL APPROVAL
1959-09-02
LATEST ACTION
1997-08-29
ROUTE
OPHTHALMIC, OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
DECADRON · ReferenceDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC, OTIC
Approval history
1997-08-29Manufacturing (CMC) · Supplement 45 · standardAP
1997-07-31Manufacturing (CMC) · Supplement 46 · standardAP
1997-03-04Manufacturing (CMC) · Supplement 44 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 43 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 42 · standardAP
1995-04-25Manufacturing (CMC) · Supplement 41 · standardAP
1994-12-22Manufacturing (CMC) · Supplement 40 · standardAP
1994-10-21Labeling · Supplement 39 · standardAP
1991-04-18Labeling · Supplement 36 · standardAP
1988-10-17Labeling · Supplement 34 · standardAP
1988-10-17Labeling · Supplement 30 · standardAP
1988-02-16Manufacturing (CMC) · Supplement 35 · standardAP
1988-02-16Labeling · Supplement 33 · standardAP
1988-02-16Labeling · Supplement 25 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 31 · standardAP
1986-02-12Manufacturing (CMC) · Supplement 28 · standardAP
1984-12-06Manufacturing (CMC) · Supplement 29 · standardAP
1984-06-14Manufacturing (CMC) · Supplement 27 · standardAP
1982-09-15Labeling · Supplement 26 · standardAP
1982-05-14Manufacturing (CMC) · Supplement 20 · standardAP
1981-10-27Manufacturing (CMC) · Supplement 24 · standardAP
1981-10-09Manufacturing (CMC) · Supplement 23 · standardAP
1981-07-15Manufacturing (CMC) · Supplement 21 · standardAP
1980-12-01Labeling · Supplement 22 · standardAP
1980-09-17Manufacturing (CMC) · Supplement 19 · standardAP
1980-05-28Labeling · Supplement 18 · standardAP
1980-01-08Labeling · Supplement 16 · standardAP
1979-08-26Labeling · Supplement 17 · standardAP
1976-05-19Labeling · Supplement 15 · standardAP
1976-04-21Manufacturing (CMC) · Supplement 14 · standardAP
1959-09-02Type 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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