FDA Orange Book · active-ingredient family
Dopamine hydrochloride
Dopamine hydrochloride is approved as 11 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019615
11
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×4 | BAXTER HLTHCARE | NDA 019615 | AP | Mar 27, 1987 | |
| DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%RLD×4 | B BRAUN | NDA 019099 | — | Oct 15, 1986 | |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×3 | HOSPIRA | NDA 018826 | AP | Sep 30, 1983 | |
| DOPAMINE HYDROCHLORIDERLD×4 | HOSPIRA | NDA 018132 | AP | Approved Prior to Jan 1, 1982 | |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% | HOSPIRA | NDA 020542 | — | Aug 30, 1995 | |
| DOPAMINE HYDROCHLORIDE | TELIGENT | NDA 018656 | — | Jun 28, 1983 | |
| DOPAMINE HYDROCHLORIDE | LYPHOMED | NDA 018549 | — | Mar 11, 1983 | |
| DOPAMINE HYDROCHLORIDE×2 | BAXTER HLTHCARE | NDA 018398 | — | Approved Prior to Jan 1, 1982 | |
| DOPAMINE HYDROCHLORIDE | INTL MEDICATION | NDA 018014 | — | Approved Prior to Jan 1, 1982 | |
| DOPAMINE HYDROCHLORIDE | WARNER CHILCOTT | NDA 018138 | — | Approved Prior to Jan 1, 1982 | |
| INTROPIN×3 | HOSPIRA | NDA 017395 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE×2 | HIKMA INTL PHARMS | ANDA 207707 | AP | Apr 11, 2018 | |
| DOPAMINE HYDROCHLORIDE | HOSPIRA | ANDA 074403 | — | May 23, 1996 | |
| DOPAMINE HYDROCHLORIDE | TEVA PARENTERAL | ANDA 072999 | — | Oct 23, 1991 | |
| DOPAMINE HYDROCHLORIDE | TEVA PARENTERAL | ANDA 073000 | — | Oct 23, 1991 | |
| DOPAMINE HYDROCHLORIDE | ABBOTT | ANDA 070656 | — | Jan 24, 1989 | |
| DOPAMINE HYDROCHLORIDE | ABBOTT | ANDA 070657 | — | Jan 24, 1989 | |
| DOPAMINE HYDROCHLORIDE | AM REGENT | ANDA 070799 | — | Feb 11, 1987 | |
| DOPAMINE HYDROCHLORIDE | AM REGENT | ANDA 070820 | — | Feb 11, 1987 | |
| DOPAMINE HYDROCHLORIDE | AM REGENT | ANDA 070826 | — | Feb 11, 1987 | |
| DOPAMINE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 070364 | — | Dec 04, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070087 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070089 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070090 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070091 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070092 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070093 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | IGI LABS INC | ANDA 070094 | — | Oct 23, 1985 | |
| DOPAMINE HYDROCHLORIDE | WARNER CHILCOTT | ANDA 070558 | — | Sep 20, 1985 | |
| DOPAMINE HYDROCHLORIDE | WARNER CHILCOTT | ANDA 070559 | — | Sep 20, 1985 | |
| DOPAMINE HYDROCHLORIDE | SMITH AND NEPHEW | ANDA 070011 | — | Aug 29, 1985 | |
| DOPAMINE HYDROCHLORIDE | SMITH AND NEPHEW | ANDA 070046 | — | Aug 29, 1985 | |
| DOPAMINE HYDROCHLORIDE | SMITH AND NEPHEW | ANDA 070047 | — | Aug 29, 1985 | |
| DOPAMINE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 070012 | — | Jun 12, 1985 | |
| DOPAMINE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 070013 | — | Jun 12, 1985 | |
| DOPAMINE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 070058 | — | Mar 20, 1985 | |
| DOPAMINE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 070059 | — | Mar 20, 1985 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Dopamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
