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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214313
Company: BAXTER HLTHCARE CORP

Products on NDA 214313

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214313

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214313s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214313Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214313Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2026	SUPPL-8	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214313Orig1s008ltr.pdf
06/11/2024	SUPPL-4	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214313Orig1s004Correctedltr.pdf
11/23/2023	SUPPL-3	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214313Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214313Orig1s003ltr.pdf
06/02/2022	SUPPL-2		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214313Orig1s002Lbl.pdf
06/02/2022	SUPPL-1	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214313Orig1s002Ltr.pdf

Labels for NDA 214313

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2023	SUPPL-3	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214313Orig1s003lbl.pdf
06/02/2022	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214313Orig1s002Lbl.pdf
01/15/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214313s000lbl.pdf

Therapeutic Equivalents for NDA 214313

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

SOLUTION;INTRAVENOUS; EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214313	BAXTER HLTHCARE CORP
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219692	SAGENT

SOLUTION;INTRAVENOUS; EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214313	BAXTER HLTHCARE CORP
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219692	SAGENT

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