APPLICATION
NDA014879
TYPE
NDA
ORIGINAL APPROVAL
1965-06-23
LATEST ACTION
2006-03-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOPRAM · ReferencePrescription
DOXAPRAM HYDROCHLORIDE 20MG/ML · INJECTABLE · INJECTION
Approval history
1998-02-13Manufacturing (CMC) · Supplement 35 · standardAP
1989-01-13Manufacturing (CMC) · Supplement 34 · standardAP
1988-05-31Manufacturing (CMC) · Supplement 33 · standardAP
1987-01-14Labeling · Supplement 31AP
1987-01-14Labeling · Supplement 30AP
1986-07-24Manufacturing (CMC) · Supplement 28 · standardAP
1986-06-18Manufacturing (CMC) · Supplement 29 · standardAP
1985-09-17Labeling · Supplement 25AP
1984-05-16Manufacturing (CMC) · Supplement 27 · standardAP
1983-03-02Manufacturing (CMC) · Supplement 26 · standardAP
1982-08-06Labeling · Supplement 23AP
1982-08-06Labeling · Supplement 21AP
1982-08-06REMS · Supplement 22 · standardAP
1982-08-06Manufacturing (CMC) · Supplement 20 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 24 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 19 · standardAP
1980-02-15Manufacturing (CMC) · Supplement 18 · standardAP
1979-09-11Manufacturing (CMC) · Supplement 9 · standardAP
1979-02-15Labeling · Supplement 15AP
1979-02-15Manufacturing (CMC) · Supplement 14 · standardAP
1978-11-30Manufacturing (CMC) · Supplement 17 · standardAP
1978-11-27Labeling · Supplement 16AP
1977-06-20Manufacturing (CMC) · Supplement 13 · standardAP
1977-04-06Manufacturing (CMC) · Supplement 12 · standardAP
1976-11-01Manufacturing (CMC) · Supplement 8 · standardAP
1976-05-03Manufacturing (CMC) · Supplement 10 · standardAP
1976-04-05Labeling · Supplement 7AP
1965-06-23Type 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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