Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020309
Company: HOSPIRA
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 |
|---|---|---|---|---|---|
| 07/28/2022 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020309Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020309Orig1s032ltr.pdf | |
| 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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 07/28/2022 | SUPPL-32 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020309Orig1s032lbl.pdf | |
| 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 | MAGNESIUM SULFATE | 4GM/100ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207967 | B BRAUN MEDICAL INC |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/100ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216597 | AMNEAL |
| 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 | 209642 | MILLA PHARMS |
| 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 | MAGNESIUM SULFATE | 4GM/50ML (80MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207967 | B BRAUN MEDICAL INC |
| 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 |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/50ML (80MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 209642 | MILLA PHARMS |
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 | MAGNESIUM SULFATE | 2GM/50ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 207967 | B BRAUN MEDICAL INC |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 2GM/50ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216597 | AMNEAL |
| 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 | 209642 | MILLA PHARMS |
| 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 |