Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202832
Company: MEDEFIL INC
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 Prescription None Yes Yes
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 18MG/2ML (9MG/ML) INJECTABLE;INJECTION Prescription None Yes Yes
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 22.5MG/2.5ML (9MG/ML) INJECTABLE;INJECTION Prescription None Yes Yes
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 27MG/3ML (9MG/ML) INJECTABLE;INJECTION Prescription None Yes Yes
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 45MG/5ML (9MG/ML) INJECTABLE;INJECTION Prescription None Yes Yes
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) INJECTABLE;INJECTION 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
01/06/2012 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
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-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf
09/27/2012 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf

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