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FDA ANDA · ANDA062774

CEFADROXIL

Sponsor: TEVA PHARMS

APPLICATION
ANDA062774
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-08
LATEST ACTION
2012-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CEFADROXILPrescription
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 1GM BASE · TABLET · ORAL

Approval history

2012-04-18Labeling · Supplement 16 — Label ↗AP
2008-06-30Labeling · Supplement 14AP
1999-08-23Manufacturing (CMC) · Supplement 8AP
1999-08-23Manufacturing (CMC) · Supplement 6AP
1999-08-23Labeling · Supplement 9AP
1999-08-23Manufacturing (CMC) · Supplement 7AP
1999-08-20Manufacturing (CMC) · Supplement 10AP
1998-12-09Manufacturing (CMC) · Supplement 5AP
1997-05-30Manufacturing (CMC) · Supplement 4AP
1992-04-21Labeling · Supplement 3AP
1992-04-21Manufacturing (CMC) · Supplement 1AP
1987-04-08OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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