FDA Orange Book · active-ingredient family
Dobutamine hydrochloride
Dobutamine hydrochloride is approved as 4 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 020255
4
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×4 | BAXTER HLTHCARE | NDA 020255 | AP | Oct 19, 1993 | |
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×4 | HOSPIRA | NDA 020201 | AP | Oct 19, 1993 | |
| DOBUTREXRLD | LILLY | NDA 017820 | — | Approved Prior to Jan 1, 1982 | |
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%×3 | HOSPIRA | NDA 020269 | — | Oct 19, 1993 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOBUTAMINE HYDROCHLORIDE | SLATE RUN PHARMA | ANDA 216131 | AP | Dec 21, 2022 | |
| DOBUTAMINE HYDROCHLORIDE | LUITPOLD | ANDA 074545 | — | Jun 25, 1998 | |
| DOBUTAMINE HYDROCHLORIDE | DR REDDYS | ANDA 074995 | — | Mar 31, 1998 | |
| DOBUTAMINE HYDROCHLORIDE | WATSON LABS INC | ANDA 074279 | — | Feb 18, 1998 | |
| DOBUTAMINE HYDROCHLORIDE | HOSPIRA | ANDA 074634 | — | Sep 27, 1996 | |
| DOBUTAMINE HYDROCHLORIDE | BAXTER HLTHCARE | ANDA 074381 | — | Sep 26, 1996 | |
| DOBUTAMINE HYDROCHLORIDE | TELIGENT | ANDA 074098 | — | Feb 21, 1995 | |
| DOBUTAMINE HYDROCHLORIDE | HOSPIRA | ANDA 074292 | — | Feb 16, 1995 | |
| DOBUTAMINE HYDROCHLORIDE | HIKMA | ANDA 074277 | AP | Oct 31, 1994 | |
| DOBUTAMINE HYDROCHLORIDE | WATSON LABS | ANDA 074114 | — | Nov 30, 1993 | |
| DOBUTAMINE HYDROCHLORIDE | HOSPIRA | ANDA 074086 | AP | Nov 29, 1993 | |
| DOBUTAMINE HYDROCHLORIDE | TEVA PARENTERAL | ANDA 074206 | — | Oct 19, 1993 |
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.
Dobutamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
