APPLICATION
ANDA071068
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-25
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 18 · standardAP
2021-02-08Labeling · Supplement 17 · standardAP
2016-12-16Labeling · Supplement 15 · standardAP
1993-10-01Labeling · Supplement 13AP
1990-11-19Manufacturing (CMC) · Supplement 12AP
1989-04-26Manufacturing (CMC) · Supplement 9AP
1989-04-26Manufacturing (CMC) · Supplement 7AP
1989-04-26Manufacturing (CMC) · Supplement 8AP
1988-12-06Labeling · Supplement 6AP
1988-08-18Labeling · Supplement 5AP
1987-07-30Manufacturing (CMC) · Supplement 1AP
1987-07-30Manufacturing (CMC) · Supplement 2AP
1986-11-25OriginalAP
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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