APPLICATION
NDA012813
TYPE
NDA
ORIGINAL APPROVAL
1961-09-18
LATEST ACTION
2017-07-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
BLEPHAMIDE · ReferenceDiscontinued
PREDNISOLONE ACETATE 0.2%, SULFACETAMIDE SODIUM 10% · SUSPENSION · OPHTHALMIC
Approval history
2003-03-19Labeling · Supplement 57 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 54 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 53 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 52 · standardAP
2001-03-26Manufacturing (CMC) · Supplement 51 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 50 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 48 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 49 · standardAP
1999-12-03Manufacturing (CMC) · Supplement 47 · standardAP
1998-08-03Manufacturing (CMC) · Supplement 29 · standardAP
1998-08-03Labeling · Supplement 43 · standardAP
1998-05-21Manufacturing (CMC) · Supplement 45 · standardAP
1998-01-09Manufacturing (CMC) · Supplement 46 · standardAP
1997-09-30Manufacturing (CMC) · Supplement 44 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 42 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 40 · standardAP
1994-06-22Manufacturing (CMC) · Supplement 41 · standardAP
1993-04-13Manufacturing (CMC) · Supplement 39 · standardAP
1990-08-06Manufacturing (CMC) · Supplement 38 · standardAP
1989-11-07Manufacturing (CMC) · Supplement 37 · standardAP
1989-03-14Manufacturing (CMC) · Supplement 36 · standardAP
1986-11-10Manufacturing (CMC) · Supplement 35 · standardAP
1986-07-18Manufacturing (CMC) · Supplement 33 · standardAP
1986-07-07Manufacturing (CMC) · Supplement 32 · standardAP
1986-03-14Manufacturing (CMC) · Supplement 34 · standardAP
1985-08-23Manufacturing (CMC) · Supplement 31 · standardAP
1985-07-09Manufacturing (CMC) · Supplement 30 · standardAP
1982-09-15Manufacturing (CMC) · Supplement 23 · standardAP
1982-09-15Manufacturing (CMC) · Supplement 24 · standardAP
1981-09-25Manufacturing (CMC) · Supplement 25 · standardAP
1980-05-08Manufacturing (CMC) · Supplement 21 · standardAP
1978-11-07Manufacturing (CMC) · Supplement 20 · standardAP
1961-09-18Type 4 - New Combination · 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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