Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201157
Company: PHARM ASSOC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription AA 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
06/04/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
07/08/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
07/08/2020 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/08/2020 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

LEVETIRACETAM

SOLUTION;ORAL; 100MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KEPPRA LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription Yes AA 021505 UCB INC
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 078582 ACI HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 078976 ACTAVIS MID ATLANTIC
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090601 AKORN
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 203067 ALEMBIC LABS
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090992 AMNEAL PHARMS
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 079063 AUROBINDO PHARMA LTD
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 079120 BRECKENRIDGE
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 203052 HETERO LABS LTD III
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090079 LANNETT CO INC
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090263 LANNETT CO INC
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090893 LUPIN LTD
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 201157 PHARM ASSOC
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 078774 TARO
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090461 TRIS PHARMA INC
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;ORAL Prescription No AA 090028 WOCKHARDT BIO AG

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