APPLICATION
ANDA203482
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-23
LATEST ACTION
2023-11-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TEMAZEPAMPrescription
TEMAZEPAM 22.5MG · CAPSULE · ORAL
TEMAZEPAMPrescription
TEMAZEPAM 7.5MG · CAPSULE · ORAL
TEMAZEPAMPrescription
TEMAZEPAM 30MG · CAPSULE · ORAL
TEMAZEPAMPrescription
TEMAZEPAM 15MG · CAPSULE · ORAL
Approval history
2023-11-17Labeling · Supplement 16 · standardAP
2023-01-11Labeling · Supplement 9 · standardAP
2023-01-11Labeling · Supplement 12 · standardAP
2023-01-11Labeling · Supplement 3 · standardAP
2023-01-11Labeling · Supplement 1 · standardAP
2016-05-23UNKNOWN · OriginalAP
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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