APPLICATION
ANDA074312
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2023-11-18
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG/ML · CONCENTRATE · ORAL
Approval history
2023-11-18Labeling · Supplement 17 · standardAP
2021-06-16Manufacturing (CMC) · Supplement 16 · unknownAP
2017-03-31Labeling · Supplement 13AP
2007-11-28Labeling · Supplement 11AP
2001-09-05Manufacturing (CMC) · Supplement 6AP
2001-07-27Manufacturing (CMC) · Supplement 5AP
2001-06-21Labeling · Supplement 4AP
1997-08-12Labeling · Supplement 3AP
1996-08-28Manufacturing (CMC) · Supplement 2AP
1994-01-07Labeling · 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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