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FDA ANDA · ANDA071717

FLURAZEPAM HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA071717
TYPE
ANDA
ORIGINAL APPROVAL
1991-07-31
LATEST ACTION
2016-12-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FLURAZEPAM HYDROCHLORIDEDiscontinued
FLURAZEPAM HYDROCHLORIDE 30MG · CAPSULE · ORAL
FLURAZEPAM HYDROCHLORIDEDiscontinued
FLURAZEPAM HYDROCHLORIDE 15MG · CAPSULE · ORAL

Approval history

2016-12-16Labeling · Supplement 4 · standardAP
1994-01-24Manufacturing (CMC) · Supplement 2AP
1993-08-25Labeling · Supplement 1AP
1991-07-31OriginalAP
VIEW ON DRUGS@FDA ↗

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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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