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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202832
Company: MEDEFIL INC

Products on NDA 202832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	9MG/ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	18MG/2ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	22.5MG/2.5ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	27MG/3ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202832

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2012	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/2012/202832s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202832_sodiumc_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2022	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202832Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202832Orig1s006ltr.pdf
11/29/2017	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202832Orig1s002ltr.pdf
09/27/2012	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832Orig1s001ltr.pdf

Labels for NDA 202832

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2022	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202832Orig1s006lbl.pdf
09/27/2012	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf
09/27/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf

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