APPLICATION
NDA013422
TYPE
NDA
ORIGINAL APPROVAL
1962-06-20
LATEST ACTION
2021-12-10
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
MAXIDEX · ReferencePrescription
DEXAMETHASONE 0.1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2016-08-05Manufacturing (CMC) · Supplement 43 · standardAP
2016-03-10Manufacturing (CMC) · Supplement 42 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 41 · standardAP
2013-09-27Manufacturing (CMC) · Supplement 40 · standardAP
2002-12-11Manufacturing (CMC) · Supplement 34 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 33 · standardAP
2000-02-04Manufacturing (CMC) · Supplement 32 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 31 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 30 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 28 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 29 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 27 · standardAP
1996-10-17Manufacturing (CMC) · Supplement 25 · standardAP
1996-09-26Labeling · Supplement 24 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 23 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 21 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 22 · standardAP
1995-06-14Manufacturing (CMC) · Supplement 20 · standardAP
1990-05-31Manufacturing (CMC) · Supplement 4 · standardAP
1989-12-06Manufacturing (CMC) · Supplement 18 · standardAP
1989-11-28Manufacturing (CMC) · Supplement 19 · standardAP
1988-03-02Manufacturing (CMC) · Supplement 17 · standardAP
1984-08-08Manufacturing (CMC) · Supplement 14 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 16 · standardAP
1983-08-05Manufacturing (CMC) · Supplement 15 · standardAP
1981-08-05Manufacturing (CMC) · Supplement 13 · standardAP
1979-07-06Manufacturing (CMC) · Supplement 11 · standardAP
1979-07-06Labeling · Supplement 10AP
1962-06-20Type 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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