APPLICATION
ANDA070820
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-11
LATEST ACTION
2021-06-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOPAMINE HYDROCHLORIDEDiscontinued
DOPAMINE HYDROCHLORIDE 80MG/ML · INJECTABLE · INJECTION
Approval history
2021-06-21Labeling · Supplement 17 · standardAP
2001-11-07Labeling · Supplement 11AP
1998-01-09Manufacturing (CMC) · Supplement 9AP
1997-11-07Labeling · Supplement 10AP
1996-09-24Labeling · Supplement 8AP
1996-02-28Manufacturing (CMC) · Supplement 7AP
1993-06-30Manufacturing (CMC) · Supplement 6AP
1992-10-27Labeling · Supplement 5AP
1992-08-26Labeling · Supplement 4AP
1992-02-05Manufacturing (CMC) · Supplement 2AP
1989-06-30Manufacturing (CMC) · Supplement 3AP
1989-06-30Manufacturing (CMC) · Supplement 1AP
1987-02-11OriginalAP
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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