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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204754
Company: AIPING PHARM 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
08/26/2016 ORIG-1 Approval STANDARD

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 201464 PHARMADAX 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 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 201464 PHARMADAX 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 205130 SCIEGEN PHARMS INC
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