Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021872
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEPPRA LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/31/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021872s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf
04/24/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf
10/26/2016 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf
04/06/2016 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021872Orig1s021ltr.pdf
08/14/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/07/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf
03/10/2015 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf
10/30/2014 SUPPL-16 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021872Orig1s016ltr.pdf
03/07/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf
07/25/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf
07/25/2013 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf
05/16/2008 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021872s005ltr.pdf
09/12/2007 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf
09/12/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s024lbl.pdf
04/24/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s023lbl.pdf
10/26/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s022lbl.pdf
04/06/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf
03/10/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf
03/10/2015 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf
03/10/2015 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf
10/30/2014 SUPPL-16 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf
08/07/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s018lbl.pdf
03/07/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf
07/25/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf
07/25/2013 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf
05/16/2008 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf
09/12/2007 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf
09/12/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf
07/31/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf

KEPPRA

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 209934 AKORN
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204312 AUROBINDO PHARMA LTD
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090813 FRESENIUS KABI USA
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 206838 JUBILANT GENERICS
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 203308 MYLAN LABS LTD
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
LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE;INTRAVENOUS 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