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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214628
Company: LONG GROVE PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE NOREPINEPHRINE BITARTRATE EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE 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
10/06/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214628Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214628Orig1s000TOC.cfm
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