Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 203993
Company: LUNDBECK PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONFI CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription AB 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
12/14/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203993Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993_onfi_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2018 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202067Orig1s005,203993Orig1s007ltr.pdf
12/16/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203993s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202067Orig1s004,203993Orig1s005ltr.pdf
06/16/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/2014 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993Orig1s003ltr.pdf
11/21/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993Orig1s002ltr.pdf
01/16/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/15/2018 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf
12/16/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203993s005lbl.pdf
12/09/2014 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf
11/21/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf
12/14/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf

ONFI

SUSPENSION;ORAL; 2.5MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210039 AMNEAL PHARMS LLC
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 208819 BIONPHARMA INC
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 209715 HIKMA
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210546 LUPIN LTD
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 211259 MYLAN
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210569 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210746 VISTAPHARM
ONFI CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription Yes AB 203993 LUNDBECK PHARMS LLC

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