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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202869
Company: HOSPIRA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS 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
04/06/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202869Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2021 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
07/13/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
07/13/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
07/13/2021 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
07/13/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
07/13/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
07/13/2021 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVETIRACETAM

INJECTABLE;INTRAVENOUS; 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;INTRAVENOUS Prescription Yes AP 021872 UCB INC
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091485 ADRASTEA PHARMA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204312 EUGIA PHARMA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090876 FRESENIUS KABI USA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 209781 HAINAN POLY PHARM
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090981 HIKMA FARMACEUTICA
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 202869 HOSPIRA INC
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 211954 MICRO LABS
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 215980 MSN
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203308 MYLAN LABS LTD
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 209474 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091627 SAGENT PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090754 SUN PHARM INDS LTD
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