APPLICATION
ANDA061837
TYPE
ANDA
ORIGINAL APPROVAL
1974-12-24
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TETRACYCLINE HYDROCHLORIDEPrescription
TETRACYCLINE HYDROCHLORIDE 500MG · CAPSULE · ORAL
TETRACYCLINE HYDROCHLORIDEPrescription
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
Approval history
2025-03-31Labeling · Supplement 44 · standardAP
2025-03-14Labeling · Supplement 39 · standardAP
2025-03-14Labeling · Supplement 35 · standardAP
2002-05-20Manufacturing (CMC) · Supplement 24AP
1999-12-21Manufacturing (CMC) · Supplement 23AP
1999-11-10Manufacturing (CMC) · Supplement 21AP
1999-11-10Manufacturing (CMC) · Supplement 22AP
1999-10-01Manufacturing (CMC) · Supplement 19AP
1999-10-01Manufacturing (CMC) · Supplement 20AP
1999-05-20Manufacturing (CMC) · Supplement 18AP
1998-12-01Manufacturing (CMC) · Supplement 17AP
1998-07-30Manufacturing (CMC) · Supplement 16AP
1997-10-10Manufacturing (CMC) · Supplement 15AP
1996-05-08Manufacturing (CMC) · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1994-10-11Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1991-10-16Labeling · Supplement 8AP
1989-02-14Manufacturing (CMC) · Supplement 7AP
1974-12-24OriginalAP
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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