APPLICATION
ANDA071456
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-21
LATEST ACTION
2024-07-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TEMAZEPAMPrescription
TEMAZEPAM 15MG · CAPSULE · ORAL
Approval history
2024-07-26Labeling · Supplement 16 · standardAP
2024-03-14Labeling · Supplement 15 · standardAP
2019-09-20Labeling · Supplement 12 · standardAP
2012-04-17Labeling · Supplement 9AP
2004-12-14Labeling · Supplement 6AP
1993-12-28Labeling · Supplement 5AP
1991-02-04Labeling · Supplement 4AP
1989-07-31Manufacturing (CMC) · Supplement 1AP
1989-06-12Labeling · Supplement 3AP
1989-06-12Labeling · Supplement 18AP
1987-11-04Manufacturing (CMC) · Supplement 2AP
1987-04-21OriginalAP
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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