APPLICATION
ANDA070920
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-10
LATEST ACTION
2021-05-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TEMAZEPAMDiscontinued
TEMAZEPAM 30MG · CAPSULE · ORAL
TEMAZEPAMDiscontinued
TEMAZEPAM 15MG · CAPSULE · ORAL
TEMAZEPAMDiscontinued
TEMAZEPAM 7.5MG · CAPSULE · ORAL
TEMAZEPAMDiscontinued
TEMAZEPAM 22.5MG · CAPSULE · ORAL
Approval history
2021-05-21Labeling · Supplement 33 · standardAP
2019-08-26Labeling · Supplement 32 · standardAP
2019-08-26Labeling · Supplement 30 · standardAP
2016-01-04Labeling · Supplement 28 · standardAP
2003-09-25Labeling · Supplement 13AP
2001-11-07Labeling · Supplement 12AP
2001-03-01Manufacturing (CMC) · Supplement 11AP
1998-12-09Labeling · Supplement 10AP
1998-02-05Manufacturing (CMC) · Supplement 9AP
1993-10-06Manufacturing (CMC) · Supplement 8AP
1993-09-01Labeling · Supplement 6AP
1991-02-19Labeling · Supplement 5AP
1990-01-31Manufacturing (CMC) · Supplement 4AP
1988-08-19Labeling · Supplement 3AP
1988-05-10Labeling · Supplement 2AP
1986-09-19Manufacturing (CMC) · Supplement 1AP
1986-07-10OriginalAP
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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