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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206039
Company: EXELA PHARMA

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 No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/2014 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/27/2019 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

MAGNESIUM SULFATE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 5GM/10ML (500MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 206039 EXELA PHARMA
MAGNESIUM SULFATE MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription Yes AP 019316 FRESENIUS KABI USA
MAGNESIUM SULFATE MAGNESIUM SULFATE 5GM/10ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 075151 HOSPIRA
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