Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090981
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription AP 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
10/13/2011 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
09/25/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LEVETIRACETAM

INJECTABLE;IV (INFUSION); 500MG/5ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KEPPRA LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 021872 UCB INC
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 204312 AUROBINDO PHARMA LTD
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 090813 FRESENIUS KABI USA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 090876 FRESENIUS KABI USA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 090981 HIKMA FARMACEUTICA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 202869 HOSPIRA INC
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 206838 JUBILANT GENERICS
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 202143 LUITPOLD
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 203308 MYLAN LABS LTD
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 091627 SAGENT PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 090754 SUN PHARM INDS LTD
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 091485 X GEN PHARMS

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