Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018132
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 40MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 80MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 160MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 80MG/ML 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
05/19/1981 ORIG-1 Approval

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-67 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
07/02/2008 SUPPL-59 Labeling

Label is not available on this site.

10/25/2002 SUPPL-51 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-50 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/2000 SUPPL-48 Labeling

Label is not available on this site.

01/07/2000 SUPPL-47 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/09/1998 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-45 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-43 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/02/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-40 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/15/1994 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

02/24/1994 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/12/1993 SUPPL-37 Labeling

Label is not available on this site.

01/31/1992 SUPPL-36 Labeling

Label is not available on this site.

06/14/1991 SUPPL-35 Labeling

Label is not available on this site.

07/02/1991 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/02/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/03/1990 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/24/1989 SUPPL-30 Labeling

Label is not available on this site.

11/29/1988 SUPPL-29 Labeling

Label is not available on this site.

03/07/1988 SUPPL-28 Labeling

Label is not available on this site.

09/22/1987 SUPPL-27 Labeling

Label is not available on this site.

07/20/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/10/1984 SUPPL-25 Manufacturing (CMC)

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-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf

DOPAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; 40MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 40MG/ML INJECTABLE;INJECTION Prescription No AP 207707 HIKMA INTL PHARMS
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 40MG/ML INJECTABLE;INJECTION Prescription Yes AP 018132 HOSPIRA

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; 80MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 80MG/ML INJECTABLE;INJECTION Prescription No AP 207707 HIKMA INTL PHARMS
DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE 80MG/ML INJECTABLE;INJECTION Prescription Yes AP 018132 HOSPIRA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English