APPLICATION
ANDA071756
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-19
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OXAZEPAMPrescription
OXAZEPAM 10MG · CAPSULE · ORAL
OXAZEPAMPrescription
OXAZEPAM 30MG · CAPSULE · ORAL
OXAZEPAMPrescription
OXAZEPAM 15MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 26 · standardAP
2021-02-05Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 21 · standardAP
2015-04-20Labeling · Supplement 14AP
2002-11-01Labeling · Supplement 10AP
2001-11-06Manufacturing (CMC) · Supplement 9AP
2001-08-08Manufacturing (CMC) · Supplement 8AP
2001-04-11Manufacturing (CMC) · Supplement 7AP
1998-03-09Labeling · Supplement 6AP
1995-03-14Manufacturing (CMC) · Supplement 4AP
1994-03-28Manufacturing (CMC) · Supplement 5AP
1993-04-14Labeling · Supplement 3AP
1989-12-12Manufacturing (CMC) · Supplement 2AP
1989-05-12Labeling · Supplement 1AP
1988-04-19OriginalAP
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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