APPLICATION
ANDA071174
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-10
LATEST ACTION
2021-05-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TEMAZEPAMDiscontinued
TEMAZEPAM 15MG · CAPSULE · ORAL
Approval history
2021-05-26Labeling · Supplement 26 · standardAP
2019-08-12Labeling · Supplement 25 · standardAP
2019-08-12Labeling · Supplement 24 · standardAP
2011-02-04Labeling · Supplement 23AP
2009-09-14Labeling · Supplement 20AP
1998-12-01Manufacturing (CMC) · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1993-10-05Labeling · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1991-03-01Labeling · Supplement 8AP
1990-05-31Bioequivalence · Supplement 7AP
1989-01-27Labeling · Supplement 4AP
1987-04-01Manufacturing (CMC) · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.