Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020488
Company: HOSPIRA
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
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.

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

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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