APPLICATION
ANDA217875
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-24
LATEST ACTION
2023-08-24
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
2023-08-24UNKNOWN · Original · standardAP
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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