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FDA ANDA · ANDA070944

OXAZEPAM

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA070944
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-03
LATEST ACTION
2021-02-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

OXAZEPAMDiscontinued
OXAZEPAM 15MG · CAPSULE · ORAL

Approval history

2021-02-05Labeling · Supplement 34 · standardAP
2016-12-16Labeling · Supplement 33 · standardAP
2008-03-03Labeling · Supplement 30AP
2002-07-29Manufacturing (CMC) · Supplement 24AP
2001-09-12Manufacturing (CMC) · Supplement 23AP
2000-09-11Manufacturing (CMC) · Supplement 19AP
2000-09-11Labeling · Supplement 21AP
2000-01-28Manufacturing (CMC) · Supplement 20AP
1999-04-13Labeling · Supplement 16AP
1999-02-11Manufacturing (CMC) · Supplement 18AP
1999-02-11Manufacturing (CMC) · Supplement 17AP
1999-02-11Manufacturing (CMC) · Supplement 15AP
1998-12-09Manufacturing (CMC) · Supplement 14AP
1998-02-25Manufacturing (CMC) · Supplement 13AP
1997-05-30Manufacturing (CMC) · Supplement 12AP
1994-09-01Manufacturing (CMC) · Supplement 11AP
1993-10-26Labeling · Supplement 10AP
1993-07-02Manufacturing (CMC) · Supplement 9AP
1992-08-21Manufacturing (CMC) · Supplement 8AP
1992-06-10Manufacturing (CMC) · Supplement 7AP
1989-02-02Labeling · Supplement 6AP
1987-08-03OriginalAP
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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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