FDA NDA · NDA018227

AMIDATE

etomidate

Sponsor: HOSPIRA

APPLICATION

NDA018227

TYPE

NDA

ORIGINAL APPROVAL

1982-09-07

LATEST ACTION

2017-04-27

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

AMIDATE · ReferencePrescription

ETOMIDATE 2MG/ML · INJECTABLE · INJECTION

2017-04-27Labeling · Supplement 32 · standard — Letter ↗AP

2002-07-03Manufacturing (CMC) · Supplement 16 · standardAP

2002-07-03Manufacturing (CMC) · Supplement 17 · standardAP

2001-04-06Manufacturing (CMC) · Supplement 15 · standardAP

1999-04-29Manufacturing (CMC) · Supplement 13 · standardAP

1999-02-26Labeling · Supplement 12 · standard — Review ↗AP

1998-09-29Manufacturing (CMC) · Supplement 11 · standardAP

1997-04-30Manufacturing (CMC) · Supplement 10 · standardAP

1996-09-11Manufacturing (CMC) · Supplement 9 · standardAP

1994-07-01Manufacturing (CMC) · Supplement 6 · standardAP

1988-01-25Labeling · Supplement 5AP

1986-06-16Labeling · Supplement 4AP

1986-02-15Labeling · Supplement 1AP

1985-05-30Manufacturing (CMC) · Supplement 2 · standardAP

1985-05-30Labeling · Supplement 3AP

1982-09-07Type 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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