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FDA NDA · NDA018132

DOPAMINE HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
NDA018132
TYPE
NDA
ORIGINAL APPROVAL
1981-05-19
LATEST ACTION
2023-09-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DOPAMINE HYDROCHLORIDE · ReferencePrescription
DOPAMINE HYDROCHLORIDE 80MG/ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE · ReferencePrescription
DOPAMINE HYDROCHLORIDE 80MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE · ReferencePrescription
DOPAMINE HYDROCHLORIDE 160MG/100ML · INJECTABLE · INJECTION
DOPAMINE HYDROCHLORIDE · ReferencePrescription
DOPAMINE HYDROCHLORIDE 40MG/ML · INJECTABLE · INJECTION

Approval history

2023-09-12Labeling · Supplement 71 · standard — Label ↗AP
2014-05-14Labeling · Supplement 67 · standard — Letter ↗AP
2008-07-02Labeling · Supplement 59AP
2002-10-25Manufacturing (CMC) · Supplement 51AP
2001-03-22Manufacturing (CMC) · Supplement 50AP
2001-03-22Manufacturing (CMC) · Supplement 49AP
2000-01-07Labeling · Supplement 48AP
2000-01-07Manufacturing (CMC) · Supplement 47AP
1998-12-09Manufacturing (CMC) · Supplement 46AP
1996-10-22Manufacturing (CMC) · Supplement 43AP
1996-10-03Manufacturing (CMC) · Supplement 45AP
1996-09-20Manufacturing (CMC) · Supplement 40AP
1995-11-02Manufacturing (CMC) · Supplement 41AP
1994-07-15Manufacturing (CMC) · Supplement 39AP
1994-02-24Manufacturing (CMC) · Supplement 38AP
1993-01-12Labeling · Supplement 37AP
1992-01-31Labeling · Supplement 36AP
1991-07-02Manufacturing (CMC) · Supplement 34AP
1991-07-02Manufacturing (CMC) · Supplement 33AP
1991-06-14Labeling · Supplement 35AP
1990-08-03Manufacturing (CMC) · Supplement 32AP
1989-08-24Labeling · Supplement 30AP
1988-11-29Labeling · Supplement 29AP
1988-03-07Labeling · Supplement 28AP
1987-09-22Labeling · Supplement 27AP
1987-07-20Manufacturing (CMC) · Supplement 26AP
1984-09-10Manufacturing (CMC) · Supplement 25AP
1981-05-19OriginalAP
VIEW ON DRUGS@FDA ↗

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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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