APPLICATION
NDA017794
TYPE
NDA
ORIGINAL APPROVAL
1977-09-30
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ATIVAN · ReferencePrescription
LORAZEPAM 1MG · TABLET · ORAL
ATIVAN · ReferencePrescription
LORAZEPAM 2MG · TABLET · ORAL
ATIVAN · ReferencePrescription
LORAZEPAM 0.5MG · TABLET · ORAL
Approval history
1988-04-20Manufacturing (CMC) · Supplement 31 · standardAP
1987-08-04Manufacturing (CMC) · Supplement 29 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 28 · standardAP
1987-06-15Manufacturing (CMC) · Supplement 26 · standardAP
1987-02-02Manufacturing (CMC) · Supplement 25 · standardAP
1986-12-15Labeling · Supplement 22AP
1986-10-30Manufacturing (CMC) · Supplement 23 · standardAP
1986-10-29Manufacturing (CMC) · Supplement 24 · standardAP
1985-04-04Manufacturing (CMC) · Supplement 19 · standardAP
1984-12-26Manufacturing (CMC) · Supplement 20 · standardAP
1984-02-24Manufacturing (CMC) · Supplement 17 · standardAP
1984-02-02Labeling · Supplement 18AP
1983-09-29Labeling · Supplement 16AP
1983-09-29Manufacturing (CMC) · Supplement 15 · standardAP
1982-10-21Manufacturing (CMC) · Supplement 12 · standardAP
1982-09-10Manufacturing (CMC) · Supplement 11 · standardAP
1982-05-03Manufacturing (CMC) · Supplement 9 · standardAP
1982-02-26Labeling · Supplement 10AP
1980-12-18Manufacturing (CMC) · Supplement 8 · standardAP
1980-09-16Manufacturing (CMC) · Supplement 7 · standardAP
1980-09-02Labeling · Supplement 5AP
1980-09-02Labeling · Supplement 6AP
1979-01-24Labeling · Supplement 4AP
1978-09-20Labeling · Supplement 3AP
1977-09-30Type 1 - New Molecular Entity · Original · standardAP
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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