APPLICATION
ANDA072369
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-30
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLURAZEPAM HYDROCHLORIDEPrescription
FLURAZEPAM HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 8 · standardAP
2021-02-08Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 5 · standardAP
1998-07-17Manufacturing (CMC) · Supplement 4AP
1997-05-23Manufacturing (CMC) · Supplement 3AP
1993-06-23Labeling · Supplement 2AP
1989-05-09Labeling · Supplement 1AP
1989-03-30OriginalAP
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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