U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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 None Yes Yes
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE NOREPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION;INTRAVENOUS Prescription None 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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
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
Back to Top