APPLICATION
ANDA060736
TYPE
ANDA
ORIGINAL APPROVAL
1980-02-07
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 26 · standardAP
2002-07-24Manufacturing (CMC) · Supplement 23AP
2002-02-08Manufacturing (CMC) · Supplement 22AP
2001-11-02Manufacturing (CMC) · Supplement 20AP
2001-09-24Manufacturing (CMC) · Supplement 21AP
2000-12-18Manufacturing (CMC) · Supplement 18AP
2000-12-18Manufacturing (CMC) · Supplement 16AP
2000-12-18Manufacturing (CMC) · Supplement 19AP
2000-12-18Manufacturing (CMC) · Supplement 17AP
1992-05-01Labeling · Supplement 15AP
1992-01-22Labeling · Supplement 14AP
1980-02-07OriginalAP
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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