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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/08/1986 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
03/05/2018 SUPPL-24 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019316s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019316Orig1s024ltr.pdf
01/29/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/19/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/29/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/29/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019316s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019316Orig1s018ltr.pdf
12/05/2006 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019316s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019316s011ltr.pdf
10/28/1998 SUPPL-8 Labeling

Label is not available on this site.

02/07/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-3 Labeling

Label is not available on this site.

11/13/1987 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/19/1987 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/05/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019316s024lbl.pdf
03/05/2018 SUPPL-24 Labeling-Container/Carton Labels 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

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

SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 10GM/20ML (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 10GM/20ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription Yes AP 019316 FRESENIUS KABI USA
MAGNESIUM SULFATE MAGNESIUM SULFATE 10GM/20ML (500MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 202411 HOSPIRA INC

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