Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020309
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription AP Yes No
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 20GM/500ML (40MG/ML) INJECTABLE;INJECTION Prescription AP Yes No
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) INJECTABLE;INJECTION Prescription AP Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/24/1994 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020309_original_approval.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/29/2013 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020309s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020309Orig1s028ltr.pdf
11/07/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/26/2007 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020309s015ltr.pdf
11/06/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1998 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1998 SUPPL-8 Labeling

Label is not available on this site.

07/14/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1997 SUPPL-6 Labeling

Label is not available on this site.

10/23/1995 SUPPL-5 Labeling

Label is not available on this site.

03/28/1996 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/29/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/18/1995 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
05/29/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020309s028lbl.pdf

MAGNESIUM SULFATE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 4GM/100ML (40MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 211966 BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 213917 GLAND PHARMA LTD
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/100ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 209911 MYLAN LABS LTD

INJECTABLE;INJECTION; 4GM/50ML (80MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE;INJECTION Prescription No AP 211966 BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 4GM/50ML (80MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA

INJECTABLE;INJECTION; 2GM/50ML (40MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 211966 BAXTER HLTHCARE CORP
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 213917 GLAND PHARMA LTD
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 2GM/50ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 209911 MYLAN LABS LTD

INJECTABLE;INJECTION; 20GM/500ML (40MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 20GM/500ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 20GM/500ML (40MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 20GM/500ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA

INJECTABLE;INJECTION; 40GM/1000ML (40MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 206485 FRESENIUS KABI USA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020309 HOSPIRA
MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE 40GM/1000ML (40MG/ML) INJECTABLE;INJECTION Prescription No AP 207350 HQ SPCLT PHARMA

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