Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018826
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 320MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1983 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018826s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018826Orig1s047ltr.pdf | |
| 05/14/2014 | SUPPL-45 | 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 | |
| 12/16/2013 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2002 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/2001 | SUPPL-27 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18826S27ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-826S027.pdf |
| 06/05/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1997 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1995 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/07/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/14/1994 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1991 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/15/1990 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/25/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/24/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1986 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/27/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018826s047lbl.pdf | |
| 05/14/2014 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf |
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
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; 320MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 320MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019615 | BAXTER HLTHCARE |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 320MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018826 | HOSPIRA |