Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 020201
Company: HOSPIRA

Products on NDA 020201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 200MG BASE/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 100MG BASE/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 50MG BASE/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 400MG BASE/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1993	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
05/24/2019	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021201s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020201Orig1s040ltr.pdf
05/31/2016	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020201s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020201Orig1s036ltr.pdf
12/02/2002	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/05/2002	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/03/2002	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/03/2002	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/10/2001	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20201S13ltr.pdf
09/01/1999	SUPPL-12	Labeling		Label is not available on this site.
10/28/1998	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/21/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
02/17/1999	SUPPL-9	Labeling		Label is not available on this site.
08/03/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/26/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/1995	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/07/1994	SUPPL-4	Labeling		Label is not available on this site.
07/07/1994	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/19/1994	SUPPL-2	Labeling		Label is not available on this site.
02/24/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020201

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2019	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021201s040lbl.pdf
05/31/2016	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020201s036lbl.pdf

Therapeutic Equivalents for NDA 020201

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 200MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 200MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020255	BAXTER HLTHCARE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 200MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020201	HOSPIRA

INJECTABLE;INJECTION; EQ 100MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 100MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020255	BAXTER HLTHCARE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 100MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020201	HOSPIRA

INJECTABLE;INJECTION; EQ 50MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 50MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020255	BAXTER HLTHCARE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 50MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020201	HOSPIRA

INJECTABLE;INJECTION; EQ 400MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 400MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020255	BAXTER HLTHCARE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 400MG BASE/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020201	HOSPIRA