Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207160
Company: EUGIA PHARMA
Company: EUGIA PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 01/04/2017 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207160Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207160Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/23/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2020 | SUPPL-3 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/11/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/04/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207160Orig1s000lbl.pdf |
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 |