APPLICATION
ANDA071446
TYPE
ANDA
ORIGINAL APPROVAL
1993-05-21
LATEST ACTION
1994-03-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TEMAZEPAMDiscontinued
TEMAZEPAM 15MG · CAPSULE · ORAL
Approval history
1994-03-11Manufacturing (CMC) · Supplement 2AP
1994-01-27Labeling · Supplement 3AP
1993-05-21OriginalAP
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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