APPLICATION
ANDA080084
TYPE
ANDA
ORIGINAL APPROVAL
1978-07-05
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFADIAZINEDiscontinued
SULFADIAZINE 500MG · TABLET · ORAL
Approval history
2024-11-14Labeling · Supplement 20 · standardAP
2000-08-10Bioequivalence · Supplement 18AP
1991-04-22Labeling · Supplement 10AP
1991-02-08Labeling · Supplement 9AP
1990-03-06Labeling · Supplement 7AP
1983-07-26Manufacturing (CMC) · Supplement 6AP
1983-07-26Manufacturing (CMC) · Supplement 5AP
1978-07-05OriginalAP
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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