Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 202143
Company: LUITPOLD
Company: LUITPOLD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/28/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LEVETIRACETAM
INJECTABLE;IV (INFUSION); 500MG/5ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | Yes | AP | 021872 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 204312 | AUROBINDO PHARMA LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 090813 | FRESENIUS KABI USA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 090876 | FRESENIUS KABI USA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 090981 | HIKMA FARMACEUTICA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 202869 | HOSPIRA INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 206838 | JUBILANT GENERICS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 202143 | LUITPOLD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 203308 | MYLAN LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 091627 | SAGENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 090754 | SUN PHARM INDS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 091485 | X GEN PHARMS |
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