Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019099
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE 80MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE 320MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 40MG/100ML INJECTABLE;INJECTION Prescription None Yes Yes
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 160MG/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
10/15/1986 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
03/19/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/04/2005 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19099s008ltr.pdf
09/17/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-6 Labeling

Label is not available on this site.

02/07/1996 SUPPL-5 Labeling

Label is not available on this site.

10/04/1990 SUPPL-4 Labeling

Label is not available on this site.

01/20/1988 SUPPL-2 Labeling

Label is not available on this site.

01/15/1987 SUPPL-1 Labeling

Label is not available on this site.

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%

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; 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

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

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

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