APPLICATION
ANDA070683
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-16
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXAZEPAMDiscontinued
OXAZEPAM 15MG · TABLET · ORAL
Approval history
2023-01-17Labeling · Supplement 15 · standardAP
2021-02-05Labeling · Supplement 14 · standardAP
2017-04-28Labeling · Supplement 13 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 12AP
1994-12-23Manufacturing (CMC) · Supplement 11AP
1993-10-05Labeling · Supplement 10AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 7AP
1991-09-04Manufacturing (CMC) · Supplement 3AP
1990-03-13Manufacturing (CMC) · Supplement 4AP
1989-04-19Labeling · Supplement 6AP
1987-03-31Manufacturing (CMC) · Supplement 1AP
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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