APPLICATION
ANDA074818
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-19
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 28 · standardAP
2021-02-05Labeling · Supplement 27 · standardAP
2019-01-16Labeling · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 25 · standardAP
2008-10-14Labeling · Supplement 19AP
2008-08-20Labeling · Supplement 18AP
2007-12-04Labeling · Supplement 16AP
2001-04-12Manufacturing (CMC) · Supplement 4AP
2000-03-21Manufacturing (CMC) · Supplement 3AP
1998-08-21Manufacturing (CMC) · Supplement 2AP
1998-03-09Manufacturing (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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