Application 020201
- Type
- NDA
- Sponsor
- HOSPIRA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MG BASE/100ML | Yes | Yes |
| 002 | DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 100MG BASE/100ML | Yes | Yes |
| 003 | DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/100ML | Yes | Yes |
| 006 | DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MG BASE/100ML | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2346 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-2347 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 0409-3724 | Dobutamine in Dextrose | Dobutamine in Dextrose | Hospira, Inc. | NDA | Current |
| 51662-1330 | DOBUTAMINE | DOBUTAMINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1330 | DOBUTAMINE | DOBUTAMINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1330 | DOBUTAMINE | DOBUTAMINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |