Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
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 |
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 640MG/100ML | INJECTABLE;INJECTION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
03/27/1987 | 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 |
---|---|---|---|---|---|
12/11/2020 | SUPPL-27 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019615Orig1s027ltr.pdf |
07/21/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019615s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019615Orig1s024ltr.pdf | |
05/21/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/2012 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019615s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s021ltr.pdf | |
03/13/2012 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s020ltr.pdf |
06/20/2002 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19615s017LTR.pdf |
08/22/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/19/2007 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019615s014ltr.pdf |
11/23/1999 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/17/2001 | SUPPL-12 | Efficacy-New Patient Population |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19615S12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19615S012_Dopamine.pdf |
03/27/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
02/07/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
08/30/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
09/29/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/07/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/02/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1990 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/07/1989 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/28/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/15/1988 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/21/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019615s024lbl.pdf | |
06/15/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019615s021lbl.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 |