APPLICATION
ANDA070445
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-20
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLURAZEPAM HYDROCHLORIDEDiscontinued
FLURAZEPAM HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 15 · standardAP
2021-02-08Labeling · Supplement 14 · standardAP
2017-01-17Labeling · Supplement 12 · standardAP
1995-08-15Manufacturing (CMC) · Supplement 8AP
1993-07-21Labeling · Supplement 11AP
1989-08-09Labeling · Supplement 10AP
1989-07-20Bioequivalence · Supplement 9AP
1988-02-02Manufacturing (CMC) · Supplement 7AP
1986-05-05Manufacturing (CMC) · Supplement 1AP
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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