APPLICATION
ANDA060304
TYPE
ANDA
ORIGINAL APPROVAL
1964-09-02
LATEST ACTION
2023-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NEOMYCIN SULFATEPrescription
NEOMYCIN SULFATE 500MG · TABLET · ORAL
Approval history
2023-02-10Labeling · Supplement 52 · standardAP
2020-08-13Labeling · Supplement 50 · standardAP
2012-02-08Labeling · Supplement 47AP
2007-12-03Labeling · Supplement 42AP
2003-11-04Labeling · Supplement 34AP
2002-02-27Manufacturing (CMC) · Supplement 32AP
2000-09-25Manufacturing (CMC) · Supplement 31AP
2000-07-07Manufacturing (CMC) · Supplement 30AP
2000-05-16Manufacturing (CMC) · Supplement 29AP
1997-06-18Manufacturing (CMC) · Supplement 28AP
1996-04-26Manufacturing (CMC) · Supplement 27AP
1995-10-26Labeling · Supplement 26AP
1995-02-16Manufacturing (CMC) · Supplement 25AP
1995-01-11Manufacturing (CMC) · Supplement 23AP
1994-09-06Manufacturing (CMC) · Supplement 24AP
1993-09-09Labeling · Supplement 22AP
1992-10-30Labeling · Supplement 21AP
1964-09-02OriginalAP
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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