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FDA ANDA · ANDA062766

CEFADROXIL

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA062766
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-03
LATEST ACTION
1999-08-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CEFADROXILDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE · CAPSULE · ORAL

Approval history

1999-08-20Manufacturing (CMC) · Supplement 15AP
1998-12-09Manufacturing (CMC) · Supplement 14AP
1998-09-04Manufacturing (CMC) · Supplement 13AP
1998-02-24Manufacturing (CMC) · Supplement 11AP
1998-02-24Manufacturing (CMC) · Supplement 12AP
1998-02-24Manufacturing (CMC) · Supplement 10AP
1997-05-30Manufacturing (CMC) · Supplement 9AP
1997-01-15Manufacturing (CMC) · Supplement 8AP
1996-03-13Manufacturing (CMC) · Supplement 7AP
1993-02-08Manufacturing (CMC) · Supplement 6AP
1992-04-21Manufacturing (CMC) · Supplement 1AP
1992-04-21Labeling · Supplement 4AP
1987-03-03OriginalAP
VIEW ON DRUGS@FDA ↗

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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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