APPLICATION
ANDA074826
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-03
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESTAZOLAMPrescription
ESTAZOLAM 2MG · TABLET · ORAL
ESTAZOLAMPrescription
ESTAZOLAM 1MG · TABLET · ORAL
Approval history
2023-01-17Labeling · Supplement 24 · standardAP
2021-08-02Manufacturing (CMC) · Supplement 20 · unknownAP
2021-02-05Labeling · Supplement 19 · standardAP
2019-02-06Labeling · Supplement 18 · standardAP
2016-12-16Labeling · Supplement 17 · standardAP
2008-09-09Labeling · Supplement 15AP
2007-09-16Manufacturing (CMC) · Supplement 14AP
2002-07-29Manufacturing (CMC) · Supplement 10AP
2000-04-21Manufacturing (CMC) · Supplement 6AP
2000-04-21Manufacturing (CMC) · Supplement 4AP
2000-04-21Manufacturing (CMC) · Supplement 7AP
2000-04-21Manufacturing (CMC) · Supplement 5AP
2000-01-28Manufacturing (CMC) · Supplement 8AP
1999-11-23Manufacturing (CMC) · Supplement 3AP
1998-12-09Manufacturing (CMC) · Supplement 2AP
1998-02-25Manufacturing (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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