Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019099
Company: B BRAUN

Products on NDA 019099

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	Discontinued	None	Yes	No
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%	DOPAMINE HYDROCHLORIDE	320MG/100ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER	DOPAMINE HYDROCHLORIDE	40MG/100ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019099

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.