Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216597
Company: AMNEAL
Company: AMNEAL
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/15/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/12/2023 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |