Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202067
Company: LUNDBECK PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONFI CLOBAZAM 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
ONFI CLOBAZAM 10MG TABLET;ORAL Prescription AB Yes No
ONFI CLOBAZAM 20MG TABLET;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
10/21/2011 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202067s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2018 SUPPL-5 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-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202067s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202067Orig1s004,203993Orig1s005ltr.pdf
12/09/2014 SUPPL-3 Labeling-Package Insert, 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
03/01/2013 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/15/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf
12/16/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202067s004lbl.pdf
12/09/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.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
03/01/2013 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s001lbl.pdf
10/21/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf

ONFI

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 212398 ACCORD HLTHCARE
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209718 AMNEAL PHARMS CO
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 208825 BIONPHARMA INC
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209308 BRECKENRIDGE PHARM
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209795 HETERO LABS LTD III
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 210545 LUPIN LTD
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 211711 MICRO LABS
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209808 PIRAMAL HLTHCARE UK
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209687 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 208785 WEST-WARD PHARMS INT
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 211449 ZYDUS PHARMS
ONFI CLOBAZAM 10MG TABLET;ORAL Prescription Yes AB 202067 LUNDBECK PHARMS LLC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 212398 ACCORD HLTHCARE
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209718 AMNEAL PHARMS CO
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 208825 BIONPHARMA INC
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209308 BRECKENRIDGE PHARM
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209795 HETERO LABS LTD III
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 210545 LUPIN LTD
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 211711 MICRO LABS
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209808 PIRAMAL HLTHCARE UK
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209687 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 208785 WEST-WARD PHARMS INT
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 211449 ZYDUS PHARMS
ONFI CLOBAZAM 20MG TABLET;ORAL Prescription Yes AB 202067 LUNDBECK PHARMS LLC

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