Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090893
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 10/17/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2023 | SUPPL-20 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/16/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2023 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2013 | SUPPL-3 | Labeling, REMS-Modified |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LEVETIRACETAM
SOLUTION;ORAL; 100MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021505 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078582 | ACI |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078976 | ACTAVIS MID ATLANTIC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203067 | ALEMBIC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090992 | AMNEAL PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079063 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090461 | BELCHER |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079120 | BIONPHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090263 | CHARTWELL MOLECULAR |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203052 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090893 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214757 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 201157 | PHARM ASSOC |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090079 | QUAGEN |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214673 | STRIDES PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078774 | TARO |