APPLICATION
ANDA074921
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-10
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 20 · standardAP
2021-02-05Labeling · Supplement 19 · standardAP
2019-02-06Labeling · Supplement 16 · standardAP
2016-12-16Labeling · Supplement 15 · standardAP
2009-01-08Labeling · Supplement 11AP
2008-02-20Labeling · Supplement 12AP
2002-11-08Manufacturing (CMC) · Supplement 3AP
2000-07-07Manufacturing (CMC) · Supplement 2AP
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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