Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075151
Company: HOSPIRA

Products on ANDA 075151

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75151ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/26/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/17/2012	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
08/23/2004	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075151

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