APPLICATION
ANDA061147
TYPE
ANDA
ORIGINAL APPROVAL
1971-02-10
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
SUMYCINPrescription
TETRACYCLINE HYDROCHLORIDE 500MG · TABLET · ORAL
SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 100MG · TABLET · ORAL
SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 50MG · TABLET · ORAL
SUMYCINPrescription
TETRACYCLINE HYDROCHLORIDE 250MG · TABLET · ORAL
Approval history
2025-03-31Labeling · Supplement 28 · standardAP
2017-05-25Manufacturing (CMC) · Supplement 26 · unknownAP
2004-09-30Labeling · Supplement 25AP
1997-07-22Labeling · Supplement 16AP
1995-11-09Manufacturing (CMC) · Supplement 23AP
1994-06-30Manufacturing (CMC) · Supplement 22AP
1992-12-24Labeling · Supplement 21AP
1991-07-03Manufacturing (CMC) · Supplement 19AP
1991-02-23Manufacturing (CMC) · Supplement 18AP
1971-02-10OriginalAP
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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