APPLICATION
ANDA074909
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-25
LATEST ACTION
2019-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET · ORAL
Approval history
2019-12-31Labeling · Supplement 25 · standardAP
2014-10-31Manufacturing (CMC) · Supplement 19AP
2012-11-29Labeling · Supplement 21AP
2008-02-28Labeling · Supplement 17AP
2002-12-09Manufacturing (CMC) · Supplement 11AP
2002-04-19Manufacturing (CMC) · Supplement 8AP
2002-03-18Manufacturing (CMC) · Supplement 10AP
2002-03-18Manufacturing (CMC) · Supplement 9AP
2001-11-19Labeling · Supplement 7AP
2001-10-10Manufacturing (CMC) · Supplement 6AP
2001-02-16Labeling · Supplement 5AP
2000-02-01Manufacturing (CMC) · Supplement 4AP
1999-11-15Manufacturing (CMC) · Supplement 3AP
1998-08-06Manufacturing (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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