APPLICATION
ANDA074342
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2019-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.25MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET · ORAL
Approval history
2019-12-31Labeling · Supplement 47 · standardAP
2011-12-08Labeling · Supplement 35AP
2003-05-16Labeling · Supplement 16AP
2002-02-15Manufacturing (CMC) · Supplement 14AP
2001-11-02Manufacturing (CMC) · Supplement 13AP
2001-04-30Labeling · Supplement 12AP
2001-01-24Manufacturing (CMC) · Supplement 11AP
2000-03-08Labeling · Supplement 10AP
1999-11-15Manufacturing (CMC) · Supplement 8AP
1999-11-15Manufacturing (CMC) · Supplement 9AP
1998-01-27Manufacturing (CMC) · Supplement 7AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-04-01Labeling · Supplement 5AP
1996-12-12Manufacturing (CMC) · Supplement 4AP
1996-01-18Manufacturing (CMC) · Supplement 3AP
1994-09-01Manufacturing (CMC) · Supplement 1AP
1993-10-31OriginalAP
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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