NDA 19615, held by Baxter Hlthcare. Dopamine Hydrochloride.
As of Nov 14, 2026, NDA 19615 (Dopamine Hydrochloride In Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Mar 27, 1987, with 20 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration.
| Apr 17, 2001 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 1987 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Dopamine Hydrochloride In Dextrose 5% In Plastic Container80MG/100ML · injectable;injection | Dopamine Hydrochloride | RxReference drug |
| Dopamine Hydrochloride In Dextrose 5% In Plastic Container160MG/100ML · injectable;injection | Dopamine Hydrochloride | RxReference drug |
| Dopamine Hydrochloride In Dextrose 5% In Plastic Container320MG/100ML · injectable;injection | Dopamine Hydrochloride | RxReference drug |
| Dopamine Hydrochloride In Dextrose 5% In Plastic Container640MG/100ML · injectable;injection | Dopamine Hydrochloride | RxReference drug |
| Dec 11, 2020 | Supplement 27Labeling · Standard review | Approved | |
| Jul 21, 2017 | Supplement 24Labeling · Standard review | Approved | |
| May 21, 2013 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 15, 2012 | Supplement 21Labeling | Approved | |
| Mar 13, 2012 | Supplement 20Labeling · Standard review | Approved | |
| Jun 19, 2007 | Supplement 14Labeling · Standard review | Approved | |
| Jun 20, 2002 | Supplement 17Labeling · Standard review | Approved | |
| Aug 22, 2001 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2001 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 1999 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1998 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 7, 1996 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 30, 1995 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 29, 1994 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1994 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1991 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1990 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1989 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1989 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 15, 1988 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1987 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
