Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078526
Company: ORCHID HLTHCARE
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
01/15/2009 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
12/09/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/09/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/09/2014 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/12/2012 SUPPL-6 REMS-Modified

Label is not available on this site.

09/27/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/27/2010 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/27/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/20/2009 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert, REMS-Proposal

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 HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 201293 AJANTA PHARMA
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
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 078234 INVAGEN PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078154 LUPIN
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 076919 MYLAN
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078526 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 077319 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 079042 WOCKHARDT
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078918 ZYDUS PHARMS USA INC
ROWEEPRA LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

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 HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 201293 AJANTA PHARMA
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
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 078234 INVAGEN PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078154 LUPIN
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 076919 MYLAN
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078526 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 205102 SECAN PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 077319 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 079042 WOCKHARDT
ROWEEPRA LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

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 HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 201293 AJANTA PHARMA
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
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 078234 INVAGEN PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078154 LUPIN
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 076919 MYLAN
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078526 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 077319 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 079042 WOCKHARDT
ROWEEPRA LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

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