Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018132
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/19/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/12/2023 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018132Orig1s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018132Orig1s071ltr.pdf | |
| 05/14/2014 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018132Orig1s067,018826Orig1s045ltr.pdf | |
| 07/02/2008 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-51 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-50 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-47 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-45 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/22/1996 | SUPPL-43 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-40 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/15/1994 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1994 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1993 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/14/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 07/02/1991 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1991 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1990 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1989 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/29/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/07/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/22/1987 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 07/20/1987 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1984 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/12/2023 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018132Orig1s071lbl.pdf | |
| 05/14/2014 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf |
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION; 40MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207707 | HIKMA INTL PHARMS |
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |
INJECTABLE;INJECTION; 80MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019615 | BAXTER HLTHCARE |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018826 | HOSPIRA |
INJECTABLE;INJECTION; 160MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019615 | BAXTER HLTHCARE |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018826 | HOSPIRA |
INJECTABLE;INJECTION; 80MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207707 | HIKMA INTL PHARMS |
| DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |