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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019316
Company: FRESENIUS KABI USA

Products on NDA 019316

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019316

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-Container/Carton Labels, Labeling-Package Insert	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.

Labels for NDA 019316

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

Therapeutic Equivalents for NDA 019316

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

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