Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204312
Company: AUROBINDO PHARMA LTD
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
02/01/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204312Origs000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204312Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204312Origs000lbl.pdf

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English