Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018826
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
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
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 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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