APPLICATION
NDA018654
TYPE
NDA
ORIGINAL APPROVAL
1985-12-20
LATEST ACTION
2001-09-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VERSED · ReferenceDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
VERSED · ReferenceDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-09-04Labeling · Supplement 38 · standardAP
1999-12-20Manufacturing (CMC) · Supplement 37 · standardAP
1999-02-19Labeling · Supplement 28 · standardAP
1999-02-19Labeling · Supplement 24 · standardAP
1998-12-17Manufacturing (CMC) · Supplement 33 · standardAP
1998-10-23Manufacturing (CMC) · Supplement 32 · standardAP
1998-08-25Labeling · Supplement 36 · standardAP
1998-05-11Manufacturing (CMC) · Supplement 31 · standardAP
1995-07-06Manufacturing (CMC) · Supplement 26 · standardAP
1994-04-26Efficacy · Supplement 27 · standardAP
1993-07-22Manufacturing (CMC) · Supplement 25 · standardAP
1993-03-12Manufacturing (CMC) · Supplement 21 · standardAP
1993-02-26Manufacturing (CMC) · Supplement 23 · standardAP
1993-02-26Manufacturing (CMC) · Supplement 22 · standardAP
1991-09-19Labeling · Supplement 20 · standardAP
1991-09-19Labeling · Supplement 15 · standardAP
1990-10-04Manufacturing (CMC) · Supplement 17 · standardAP
1990-10-04Manufacturing (CMC) · Supplement 16 · standardAP
1989-09-29Manufacturing (CMC) · Supplement 14 · standardAP
1988-10-17Labeling · Supplement 5 · standardAP
1988-02-25Labeling · Supplement 12 · standardAP
1987-08-20Manufacturing (CMC) · Supplement 11 · standardAP
1987-05-26Manufacturing (CMC) · Supplement 10 · standardAP
1987-05-26Labeling · Supplement 9 · standardAP
1987-02-25Labeling · Supplement 8 · standardAP
1986-05-28Manufacturing (CMC) · Supplement 1 · standardAP
1986-05-28Manufacturing (CMC) · Supplement 4 · 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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