Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207350
Company: HQ SPCLT PHARMA
Company: HQ SPCLT PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 2GM/50ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/100ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/50ML (80MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 20GM/500ML (40MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 40GM/1000ML (40MG/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/06/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MAGNESIUM SULFATE IN PLASTIC CONTAINER
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; 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; 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 |