Drugs@FDA: FDA-Approved Drugs
Company: APOTEX INC
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)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091261s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/23/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2020 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/10/2020 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/26/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2014 | SUPPL-3 | 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 | 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 | 203468 | PRINSTON INC |
LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205130 | SCIEGEN PHARMS INC |