APPLICATION
ANDA060469
TYPE
ANDA
ORIGINAL APPROVAL
1971-07-13
LATEST ACTION
2026-04-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 500MG · CAPSULE · ORAL
TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 100MG · CAPSULE · ORAL
Approval history
2026-04-17Labeling · Supplement 16 · standardAP
2026-04-17Labeling · Supplement 17 · standardAP
2001-10-25Manufacturing (CMC) · Supplement 13AP
1996-11-12Labeling · Supplement 12AP
1993-06-25Labeling · Supplement 11AP
1992-09-04Labeling · Supplement 9AP
1992-07-16Labeling · Supplement 10AP
1991-07-29Manufacturing (CMC) · Supplement 6AP
1971-07-13OriginalAP
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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