Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077319
Company: OXFORD PHARMS
Company: OXFORD PHARMS
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/20/2009 | 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 |
---|---|---|---|---|---|
09/12/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2012 | SUPPL-4 | REMS-Modified, Labeling-Medication Guide |
Label is not available on this site. |
||
01/12/2010 | SUPPL-2 | REMS-Proposal, Labeling-Container/Carton Labels |
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 | 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 PHARMA |
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 | 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 PHARMA |
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 | 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 PHARMA |
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 |