Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211356
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;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 |
|---|---|---|---|---|---|---|---|
| 02/12/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVETIRACETAM IN SODIUM CHLORIDE
INJECTABLE;INTRAVENOUS; 500MG/100ML (5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209705 | B BRAUN MEDICAL INC |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 217059 | BAXTER HLTHCARE CORP |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207160 | EUGIA PHARMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206880 | GLAND PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211356 | HIKMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 202543 | HQ SPCLT PHARMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213532 | NEXUS |
INJECTABLE;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209705 | B BRAUN MEDICAL INC |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 217059 | BAXTER HLTHCARE CORP |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207160 | EUGIA PHARMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206880 | GLAND PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211356 | HIKMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 202543 | HQ SPCLT PHARMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213532 | NEXUS |
INJECTABLE;INTRAVENOUS; 1.5GM/100ML (15MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209705 | B BRAUN MEDICAL INC |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 217059 | BAXTER HLTHCARE CORP |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207160 | EUGIA PHARMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206880 | GLAND PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211356 | HIKMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 202543 | HQ SPCLT PHARMA |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213532 | NEXUS |