Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019615
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
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 AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE 80MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019099 B BRAUN
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 AND DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 160MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019099 B BRAUN
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 AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE 320MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019099 B BRAUN
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

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