APPLICATION
NDA016721
TYPE
NDA
ORIGINAL APPROVAL
1970-04-07
LATEST ACTION
2009-03-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DALMANEDiscontinued
FLURAZEPAM HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DALMANE · ReferenceDiscontinued
FLURAZEPAM HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2002-08-12Manufacturing (CMC) · Supplement 75 · priorityAP
1993-05-25Manufacturing (CMC) · Supplement 72 · priorityAP
1992-12-31Manufacturing (CMC) · Supplement 71 · priorityAP
1990-04-25Manufacturing (CMC) · Supplement 70 · priorityAP
1990-01-16Manufacturing (CMC) · Supplement 68 · priorityAP
1989-11-07Manufacturing (CMC) · Supplement 67 · priorityAP
1987-11-09Labeling · Supplement 66 · priorityAP
1984-12-11Manufacturing (CMC) · Supplement 64 · priorityAP
1982-06-15Manufacturing (CMC) · Supplement 63 · priorityAP
1982-01-28Manufacturing (CMC) · Supplement 62 · priorityAP
1981-12-22Manufacturing (CMC) · Supplement 60 · priorityAP
1981-12-22Manufacturing (CMC) · Supplement 61 · priorityAP
1981-11-05Manufacturing (CMC) · Supplement 59 · priorityAP
1981-08-04Manufacturing (CMC) · Supplement 57 · priorityAP
1981-07-17Manufacturing (CMC) · Supplement 56 · priorityAP
1981-05-06Labeling · Supplement 54 · priorityAP
1981-03-26Manufacturing (CMC) · Supplement 55 · priorityAP
1980-08-20Manufacturing (CMC) · Supplement 52 · priorityAP
1980-08-20Manufacturing (CMC) · Supplement 51 · priorityAP
1980-07-11Manufacturing (CMC) · Supplement 50 · priorityAP
1980-06-17Manufacturing (CMC) · Supplement 48 · priorityAP
1980-06-17Manufacturing (CMC) · Supplement 49 · priorityAP
1980-02-04Manufacturing (CMC) · Supplement 47 · priorityAP
1979-11-09Manufacturing (CMC) · Supplement 46 · priorityAP
1979-09-17Manufacturing (CMC) · Supplement 45 · priorityAP
1979-05-01Manufacturing (CMC) · Supplement 44 · priorityAP
1979-03-26Manufacturing (CMC) · Supplement 43 · priorityAP
1978-07-28Manufacturing (CMC) · Supplement 42 · priorityAP
1978-07-20Labeling · Supplement 40 · priorityAP
1978-07-12Manufacturing (CMC) · Supplement 41 · priorityAP
1978-07-10Labeling · Supplement 30 · priorityAP
1978-07-10Labeling · Supplement 39 · priorityAP
1978-05-02Manufacturing (CMC) · Supplement 38 · priorityAP
1977-08-02Labeling · Supplement 34 · priorityAP
1977-07-12Manufacturing (CMC) · Supplement 37 · priorityAP
1977-06-29Manufacturing (CMC) · Supplement 36 · priorityAP
1976-12-10Labeling · Supplement 32 · priorityAP
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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