Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020255
Company: BAXTER HLTHCARE
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 50MG 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 200MG 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
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
03/27/2019 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020255s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020255Orig1s020ltr.pdf
04/17/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020255Orig1s016ltr.pdf
03/05/2012 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020255s014ltr.pdf
07/24/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf
07/24/2003 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf
05/31/2001 SUPPL-8 Labeling

Label is not available on this site.

11/23/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/2000 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20255-s006_dobutamine.pdf
04/21/1999 SUPPL-5 Labeling

Label is not available on this site.

04/30/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/08/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1994 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
03/27/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020255s020lbl.pdf
04/17/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

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 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 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 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

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