Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 202533
Company: PRINSTON INC
Company: PRINSTON 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 |
|---|---|---|---|---|---|---|---|
| 07/20/2012 | 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 |
|---|---|---|---|---|---|
| 02/12/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-3 | 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 | 091557 | ACTAVIS ELIZABETH |
| 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 | 091360 | ANCHEN PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091261 | APOTEX INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202167 | DEXCEL PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204754 | ECI PHARMS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204511 | INTELLIPHARMACEUTICS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202095 | LOTUS PHARM CO LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091399 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201464 | PHARMADAX INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207175 | PHARMTAK 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 | 202524 | ROUSES POINT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203059 | SUN PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091285 | SUN PHARM INDUSTRIES |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091430 | TEVA PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091338 | TORRENT PHARMS LTD |
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 | 091557 | ACTAVIS ELIZABETH |
| 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 | 091360 | ANCHEN PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091261 | APOTEX INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202167 | DEXCEL PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204754 | ECI PHARMS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204511 | INTELLIPHARMACEUTICS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202095 | LOTUS PHARM CO LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091399 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201464 | PHARMADAX INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207175 | PHARMTAK 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 | 202524 | ROUSES POINT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203059 | SUN PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091285 | SUN PHARM INDUSTRIES |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091430 | TEVA PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091338 | TORRENT PHARMS LTD |
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