Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 019626
Company: B BRAUN

Products on NDA 019626

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DEXTROSE 2.5% IN PLASTIC CONTAINER	DEXTROSE	2.5GM/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DEXTROSE 7.7% IN PLASTIC CONTAINER	DEXTROSE	7.7GM/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/1988	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
11/20/2015	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
02/18/2015	SUPPL-30	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019626s030lbl.pdf
08/22/2014	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
02/13/2004	SUPPL-19	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19626scs019_dextrose_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19626scs019ltr.pdf
07/23/2002	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/2002	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/12/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/2000	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/1998	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/01/1993	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/26/1993	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
07/21/1993	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1991	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/1990	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/1990	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/26/1989	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1989	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/21/1989	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/21/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/16/1988	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019626

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2015	SUPPL-30	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019626s030lbl.pdf
02/13/2004	SUPPL-19	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19626scs019_dextrose_lbl.pdf

Therapeutic Equivalents for NDA 019626

DEXTROSE 10% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019626	B BRAUN
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016694	BAXTER HLTHCARE
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209448	FRESENIUS KABI USA
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018080	ICU MEDICAL INC

DEXTROSE 2.5% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016730	B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019626	B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016673	BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020179	BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019466	HOSPIRA
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	5GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019479	HOSPIRA

DEXTROSE 7.7% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

DEXTROSE 70% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 70GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019626	B BRAUN
DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020047	BAXTER HLTHCARE
DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018561	ICU MEDICAL INC
DEXTROSE 70% IN PLASTIC CONTAINER	DEXTROSE	70GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019893	ICU MEDICAL INC