APPLICATION
ANDA071427
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-12
LATEST ACTION
2023-06-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TEMAZEPAMPrescription
TEMAZEPAM 15MG · CAPSULE · ORAL
Approval history
2023-06-21Labeling · Supplement 34 · standardAP
2021-05-21Labeling · Supplement 32 · standardAP
2019-09-06Labeling · Supplement 31 · standardAP
2019-09-06Labeling · Supplement 30 · standardAP
2011-02-03Labeling · Supplement 24AP
2008-10-08Labeling · Supplement 19AP
2001-11-06Manufacturing (CMC) · Supplement 13AP
2001-08-08Manufacturing (CMC) · Supplement 11AP
2001-08-08Manufacturing (CMC) · Supplement 12AP
2000-11-30Manufacturing (CMC) · Supplement 10AP
1999-05-05Manufacturing (CMC) · Supplement 8AP
1995-03-02Manufacturing (CMC) · Supplement 6AP
1994-01-19Labeling · Supplement 5AP
1993-12-09Manufacturing (CMC) · Supplement 7AP
1991-09-09Manufacturing (CMC) · Supplement 3AP
1991-02-01Labeling · Supplement 4AP
1989-10-05Labeling · Supplement 2AP
1989-02-22Manufacturing (CMC) · Supplement 1AP
1988-01-12OriginalAP
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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