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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020488
Company: HOSPIRA

Products on NDA 020488

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	2GM/100ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020488

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/1995	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020488_original_approval.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2019	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020488Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020488Orig1s024ltr.pdf
07/14/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
11/26/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/29/2013	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020488s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020488Orig1s019ltr.pdf
11/06/2002	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/28/1998	SUPPL-3	Labeling		Label is not available on this site.
07/14/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/14/1997	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020488

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020488Orig1s024lbl.pdf
05/29/2013	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020488s019lbl.pdf

Therapeutic Equivalents for NDA 020488

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 1GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	207966	B BRAUN MEDICAL INC
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	211965	BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	206486	FRESENIUS KABI USA
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020488	HOSPIRA
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	207349	HQ SPCLT PHARMA
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MAGNESIUM SULFATE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209932	MYLAN LABS LTD

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