Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091399
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2011 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091399Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091399Orig1s000OtherActionLtrs.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/19/2023 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/16/2023 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/03/2013 | SUPPL-4 | Labeling, REMS-Modified |
Label is not available on this site. |
||
| 02/18/2014 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
LEVETIRACETAM
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA XR | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022285 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091093 | ACTAVIS LABS FL INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204754 | AIPING PHARM INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204511 | ANDA REPOSITORY |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091261 | APOTEX INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207175 | HISUN PHARM HANGZHOU |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091399 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212688 | OVERSEAS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201464 | PHARMADAX INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202533 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203468 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205130 | SCIEGEN PHARMS INC |
TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA XR | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022285 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091093 | ACTAVIS LABS FL INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204754 | AIPING PHARM INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204511 | ANDA REPOSITORY |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091261 | APOTEX INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207175 | HISUN PHARM HANGZHOU |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091399 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212688 | OVERSEAS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201464 | PHARMADAX INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202533 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203468 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205130 | SCIEGEN PHARMS INC |