Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216375
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | AB | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | AB | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 05/27/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVETIRACETAM
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | Yes | AB | 021035 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 090843 | ACCORD HLTHCARE |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078042 | ACI |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 076920 | DR REDDYS LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078154 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078526 | ORBION PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 077319 | OXFORD PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078106 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS INC |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 079042 | STALLION LABS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078960 | TARO |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078918 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | Yes | AB | 021035 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 090843 | ACCORD HLTHCARE |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078042 | ACI |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 076920 | DR REDDYS LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078154 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 076919 | MYLAN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078526 | ORBION PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 077319 | OXFORD PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078106 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 079042 | STALLION LABS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078960 | TARO |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
TABLET;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | Yes | AB | 021035 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 090843 | ACCORD HLTHCARE |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078042 | ACI |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 076920 | DR REDDYS LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078154 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 076919 | MYLAN |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078526 | ORBION PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 077319 | OXFORD PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078106 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 079042 | STALLION LABS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078960 | TARO |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
TABLET;ORAL; 1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | Yes | AB | 021035 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090843 | ACCORD HLTHCARE |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078042 | ACI |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078904 | DR REDDYS LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090025 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090261 | MYLAN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090484 | ORBION PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078106 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS INC |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 079042 | STALLION LABS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078960 | TARO |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078918 | ZYDUS PHARMS USA INC |