APPLICATION
NDA050665
TYPE
NDA
ORIGINAL APPROVAL
1991-12-23
LATEST ACTION
2016-11-22
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEFZIL · ReferenceDiscontinued
CEFPROZIL 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
CEFZIL · ReferenceDiscontinued
CEFPROZIL 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
Approval history
2004-06-23Type 3 - New Dosage Form · Original · standardAP
2001-10-01Labeling · Supplement 22 · standardAP
1999-05-13Manufacturing (CMC) · Supplement 20 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 21 · standardAP
1998-09-08Manufacturing (CMC) · Supplement 19 · standardAP
1998-01-05Manufacturing (CMC) · Supplement 18 · standardAP
1997-08-26Labeling · Supplement 15 · standardAP
1997-05-29Labeling · Supplement 17 · standardAP
1997-04-23Labeling · Supplement 16 · standardAP
1996-09-05Efficacy · Supplement 13 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 14 · standardAP
1995-08-31Labeling · Supplement 8 · standardAP
1995-08-31Labeling · Supplement 7 · standardAP
1995-05-17Efficacy · Supplement 4 · unknownAP
1995-05-09Labeling · Supplement 11 · standardAP
1995-04-10Manufacturing (CMC) · Supplement 9 · standardAP
1995-02-08Labeling · Supplement 10 · standardAP
1993-12-07Manufacturing (CMC) · Supplement 6 · standardAP
1993-12-07Manufacturing (CMC) · Supplement 5 · standardAP
1992-12-31Efficacy · Supplement 2AP
1991-12-23Type 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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