APPLICATION
ANDA062927
TYPE
ANDA
ORIGINAL APPROVAL
1988-11-25
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
AMOXICILLINDiscontinued
AMOXICILLIN 250MG/5ML · FOR SUSPENSION · ORAL
AMOXICILLINDiscontinued
AMOXICILLIN 125MG/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 29 · standardAP
2024-04-23Labeling · Supplement 26 · standardAP
2024-04-23Labeling · Supplement 27 · standardAP
2024-04-23Labeling · Supplement 28 · standardAP
2001-11-30Labeling · Supplement 16AP
2001-09-05Manufacturing (CMC) · Supplement 14AP
2001-07-13Labeling · Supplement 15AP
2001-03-12Labeling · Supplement 13AP
2000-11-27Labeling · Supplement 12AP
1999-11-17Labeling · Supplement 10AP
1999-06-09Manufacturing (CMC) · Supplement 8AP
1999-01-25Labeling · Supplement 9AP
1996-05-14Manufacturing (CMC) · Supplement 7AP
1994-06-02Manufacturing (CMC) · Supplement 5AP
1994-06-02Labeling · Supplement 6AP
1992-11-17Labeling · Supplement 3AP
1992-11-17Manufacturing (CMC) · Supplement 2AP
1988-11-25OriginalAP
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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