APPLICATION
ANDA062935
TYPE
ANDA
ORIGINAL APPROVAL
1988-11-23
LATEST ACTION
2025-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PENICILLIN V POTASSIUMPrescription
PENICILLIN V POTASSIUM EQ 500MG BASE · TABLET · ORAL
Approval history
2025-10-31Labeling · Supplement 11 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 6AP
1994-01-06Labeling · Supplement 5AP
1992-12-04Manufacturing (CMC) · Supplement 2AP
1992-12-04Labeling · Supplement 3AP
1992-05-18Manufacturing (CMC) · Supplement 4AP
1989-12-01Manufacturing (CMC) · Supplement 1AP
1988-11-23OriginalAP
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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