Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202543
Company: HQ SPCLT PHARMA
Company: HQ SPCLT 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 | Yes | Yes |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/09/2011 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202543lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202543s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202543_levetiracetam_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202543Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202543s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202543Orig1s024ltr.pdf | |
| 04/13/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202543s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202543Orig1s019ltr.pdf | |
| 11/21/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202543s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202543Orig1s015ltr.pdf | |
| 07/12/2018 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202543s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202543Orig1s011Ltr.pdf | |
| 06/12/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202543s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202543Orig1s010ltr.pdf | |
| 11/18/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202543Orig1s008,s009ltr.pdf | |
| 11/18/2016 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202543Orig1s008,s009ltr.pdf | |
| 07/14/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2012 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202543s024lbl.pdf | |
| 04/13/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202543s019lbl.pdf | |
| 11/21/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202543s015lbl.pdf | |
| 07/12/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202543s011lbl.pdf | |
| 06/12/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202543s010lbl.pdf | |
| 11/18/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf | |
| 11/18/2016 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf | |
| 11/09/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202543lbl.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 |