APPLICATION
ANDA070454
TYPE
ANDA
ORIGINAL APPROVAL
1986-08-04
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLURAZEPAM HYDROCHLORIDEDiscontinued
FLURAZEPAM HYDROCHLORIDE 15MG · CAPSULE · ORAL
Approval history
2023-01-17Labeling · Supplement 21 · standardAP
2021-02-08Labeling · Supplement 20 · standardAP
2019-02-06Labeling · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 17AP
1994-12-23Manufacturing (CMC) · Supplement 16AP
1993-09-17Labeling · Supplement 15AP
1992-07-07Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 14AP
1992-04-03Manufacturing (CMC) · Supplement 12AP
1989-05-01Labeling · Supplement 10AP
1987-12-22Manufacturing (CMC) · Supplement 8AP
1987-06-08Manufacturing (CMC) · Supplement 6AP
1987-03-27Manufacturing (CMC) · Supplement 7AP
1986-11-13Manufacturing (CMC) · Supplement 3AP
1986-11-13Manufacturing (CMC) · Supplement 4AP
1986-11-13Manufacturing (CMC) · Supplement 2AP
1986-08-04OriginalAP
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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