APPLICATION
ANDA060783
TYPE
ANDA
ORIGINAL APPROVAL
1968-07-17
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 500MG · CAPSULE · ORAL
TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
Approval history
2025-03-31Labeling · Supplement 28 · standardAP
2014-08-09Labeling · Supplement 26 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 24AP
1998-02-05Manufacturing (CMC) · Supplement 25AP
1995-05-30Manufacturing (CMC) · Supplement 23AP
1993-10-22Manufacturing (CMC) · Supplement 22AP
1993-10-22Manufacturing (CMC) · Supplement 21AP
1992-05-11Labeling · Supplement 19AP
1990-01-31Manufacturing (CMC) · Supplement 18AP
1990-01-31Manufacturing (CMC) · Supplement 17AP
1989-04-25Manufacturing (CMC) · Supplement 15AP
1968-07-17OriginalAP
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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