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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020179
Company: BAXTER HLTHCARE

Products on NDA 020179

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020179

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/1992	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
08/05/2019	SUPPL-56		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020179s056lbl.pdf
12/07/2022	SUPPL-26	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020178Orig1s031ltr;020179Orig1s026ltr.pdf
08/05/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121,017521s069,020047s021,020179s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016673Orig1s149, 016694Orig1s121, 020047Orig1s021, 020179Orig1s012ltr.pdf
11/20/2003	SUPPL-7	Labeling		Label is not available on this site.
05/04/2001	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/29/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/15/1999	SUPPL-3	Labeling		Label is not available on this site.
02/18/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020179

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2019	SUPPL-56	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020179s056lbl.pdf
08/05/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121,017521s069,020047s021,020179s012lbl.pdf

Therapeutic Equivalents for NDA 020179

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

INJECTABLE;INJECTION; 50MG/ML
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	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016730	B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016673	BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020179	BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207449	FRESENIUS KABI USA
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016367	OTSUKA ICU MEDCL

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