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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203993
Company: LUNDBECK PHARMS LLC

Medication Guide

Summary Review

Products on NDA 203993

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203993

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
03/12/2024	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202067s008,203993s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202067Orig1s008, 203993Orig1s010ltr.pdf
01/13/2023	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202067Orig1s007;203993Orig1s009ltr.pdf
02/05/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202067Orig1s006; 203993Orig1s008ltr.pdf
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.

Labels for NDA 203993

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2024	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202067s008,203993s010lbl.pdf
03/12/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202067s008,203993s010lbl.pdf
01/13/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf
01/13/2023	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf
02/05/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf
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

Therapeutic Equivalents for NDA 203993

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	213039	ALKEM LABS LTD
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210039	AMNEAL
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	214404	AUROBINDO PHARMA LTD
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	208819	BIONPHARMA
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	213110	CHARTWELL MOLECULAR
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	209796	HETERO LABS LTD III
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210546	LUPIN LTD
CLOBAZAM	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210978	TARO
ONFI	CLOBAZAM	2.5MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	203993	LUNDBECK PHARMS LLC

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