APPLICATION
NDA016624
TYPE
NDA
ORIGINAL APPROVAL
1969-11-28
LATEST ACTION
2002-08-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
HMSDiscontinued
MEDRYSONE 1% · SUSPENSION · OPHTHALMIC
Approval history
2002-04-12Manufacturing (CMC) · Supplement 43 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 42 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 40 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 39 · standardAP
1998-09-28Manufacturing (CMC) · Supplement 38 · standardAP
1996-12-05Manufacturing (CMC) · Supplement 37 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 36 · standardAP
1993-08-13Manufacturing (CMC) · Supplement 35 · standardAP
1989-11-07Manufacturing (CMC) · Supplement 32 · standardAP
1989-10-17Manufacturing (CMC) · Supplement 34 · standardAP
1989-03-30Manufacturing (CMC) · Supplement 33 · standardAP
1986-07-18Manufacturing (CMC) · Supplement 31 · standardAP
1982-09-17Manufacturing (CMC) · Supplement 26 · standardAP
1982-05-12Manufacturing (CMC) · Supplement 27 · standardAP
1980-05-22Manufacturing (CMC) · Supplement 25 · standardAP
1979-10-02Manufacturing (CMC) · Supplement 24 · standardAP
1976-10-27Manufacturing (CMC) · Supplement 15 · standardAP
1976-10-27Labeling · Supplement 21 · standardAP
1976-10-27Labeling · Supplement 13 · standardAP
1976-10-27Labeling · Supplement 22 · standardAP
1976-10-27Labeling · Supplement 20 · standardAP
1976-04-07Manufacturing (CMC) · Supplement 14 · standardAP
1975-12-11Labeling · Supplement 17 · standardAP
1975-12-11Manufacturing (CMC) · Supplement 18 · standardAP
1975-06-26Supplement · Supplement 9 · standardAP
1975-05-27Labeling · Supplement 16 · standardAP
1974-11-25Labeling · Supplement 11 · standardAP
1974-11-25Manufacturing (CMC) · Supplement 12 · standardAP
1969-11-28Type 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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