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FDA ANDA · ANDA060704

TETRACYCLINE HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA060704
TYPE
ANDA
ORIGINAL APPROVAL
1963-07-05
LATEST ACTION
2014-01-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 500MG · CAPSULE · ORAL

Approval history

2014-01-27Labeling · Supplement 35LabelAP
2002-06-12Manufacturing (CMC) · Supplement 27AP
2001-09-12Manufacturing (CMC) · Supplement 26AP
2001-09-07Manufacturing (CMC) · Supplement 25AP
2000-08-04Manufacturing (CMC) · Supplement 23AP
2000-08-04Labeling · Supplement 24AP
2000-03-30Labeling · Supplement 22AP
2000-03-30Manufacturing (CMC) · Supplement 20AP
2000-01-28Manufacturing (CMC) · Supplement 21AP
1999-08-20Manufacturing (CMC) · Supplement 19AP
1999-07-02Manufacturing (CMC) · Supplement 17AP
1999-07-02Manufacturing (CMC) · Supplement 15AP
1999-07-02Manufacturing (CMC) · Supplement 18AP
1999-07-02Manufacturing (CMC) · Supplement 16AP
1999-07-02Manufacturing (CMC) · Supplement 14AP
1998-12-09Manufacturing (CMC) · Supplement 13AP
1997-05-30Manufacturing (CMC) · Supplement 12AP
1996-06-04Manufacturing (CMC) · Supplement 11AP
1996-04-30Manufacturing (CMC) · Supplement 7AP
1996-01-31Manufacturing (CMC) · Supplement 8AP
1996-01-31Labeling · Supplement 9AP
1996-01-31Manufacturing (CMC) · Supplement 10AP
1993-09-24Manufacturing (CMC) · Supplement 6AP
1992-09-03Manufacturing (CMC) · Supplement 4AP
1992-09-03Manufacturing (CMC) · Supplement 5AP
1992-06-23Manufacturing (CMC) · Supplement 2AP
1992-05-27Labeling · Supplement 3AP
1991-08-22Labeling · Supplement 1AP
1963-07-05OriginalAP
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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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