APPLICATION
ANDA213003
TYPE
ANDA
ORIGINAL APPROVAL
2022-12-28
LATEST ACTION
2023-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIAZOLAMPrescription
TRIAZOLAM 0.25MG · TABLET · ORAL
TRIAZOLAMPrescription
TRIAZOLAM 0.125MG · TABLET · ORAL
Approval history
2023-05-25Labeling · Supplement 1 · standardAP
2022-12-28UNKNOWN · 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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