Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 214628

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214628

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-4	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214628Orig1s004Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214628Orig1s004Correctedltr.pdf

Labels for NDA 214628

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-4	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214628Orig1s004Correctedlbl.pdf