Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019316
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAGNESIUM SULFATE MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription AP Yes Yes
MAGNESIUM SULFATE MAGNESIUM SULFATE 1GM/2ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None Yes Yes
MAGNESIUM SULFATE MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription AP Yes Yes
MAGNESIUM SULFATE MAGNESIUM SULFATE 25GM/50ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/05/2018 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019316s024lbl.pdf
03/05/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019316s024lbl.pdf
05/29/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019316s018lbl.pdf
12/05/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019316s011lbl.pdf

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