Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217461
Company: SQUARE PHARMS PLC
Company: SQUARE PHARMS PLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | No |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | No |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | No |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | AP | No | 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 |
|---|---|---|---|---|---|---|---|
| 07/09/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MAGNESIUM SULFATE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 1GM/2ML (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 | 1GM/2ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 219777 | ASPIRO |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AP | 019316 | FRESENIUS KABI USA |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 1GM/2ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 217461 | SQUARE PHARMS PLC |
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 | 219777 | ASPIRO |
| 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 |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 217461 | SQUARE PHARMS PLC |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 10GM/20ML (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 | 10GM/20ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 219777 | ASPIRO |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AP | 019316 | FRESENIUS KABI USA |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 202411 | HOSPIRA |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 10GM/20ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 217461 | SQUARE PHARMS PLC |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 25GM/50ML (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 | 25GM/50ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 219777 | ASPIRO |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AP | 019316 | FRESENIUS KABI USA |
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | 25GM/50ML (500MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 217461 | SQUARE PHARMS PLC |