APPLICATION
ANDA070345
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-12
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLURAZEPAM HYDROCHLORIDEPrescription
FLURAZEPAM HYDROCHLORIDE 15MG · CAPSULE · ORAL
FLURAZEPAM HYDROCHLORIDEPrescription
FLURAZEPAM HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 26 · standardAP
2021-02-08Labeling · Supplement 23 · standardAP
2019-02-06Labeling · Supplement 20 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2015-01-15Labeling · Supplement 17 · standardAP
2010-09-28Labeling · Supplement 16AP
2002-09-18Labeling · Supplement 11AP
1998-02-25Manufacturing (CMC) · Supplement 10AP
1998-02-05Manufacturing (CMC) · Supplement 9AP
1993-10-19Manufacturing (CMC) · Supplement 7AP
1993-04-29Labeling · Supplement 6AP
1990-01-31Manufacturing (CMC) · Supplement 5AP
1989-06-16Labeling · Supplement 4AP
1988-02-18Manufacturing (CMC) · Supplement 3AP
1985-06-12OriginalAP
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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