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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203479
Company: TASMAN PHARMA

REMS

Summary Review

Products on NDA 203479

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERSACLOZ	CLOZAPINE	50MG/ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479_versacloz_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203479s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203479Orig1s021ltr.pdf
11/10/2021	SUPPL-17	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203479Orig1s017ltr.pdf
07/29/2021	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203479Orig1s016ltr.pdf
02/18/2021	SUPPL-15	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203479Orig1s015ltr.pdf
04/14/2020	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203479s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203479Orig1s014ltr.pdf
07/29/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203479s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203479Orig1s012ltr.pdf
01/16/2019	SUPPL-11	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203479Orig1s011ltr.pdf
02/23/2017	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203479s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203479Orig1s010ltr.pdf
09/30/2015	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf
09/15/2015	SUPPL-8	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf
09/15/2015	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf
02/18/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/29/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/25/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/22/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s002ltr.pdf
12/05/2013	SUPPL-1	REMS-Modified, REMS-Assessment	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s001ltr.pdf

Labels for NDA 203479

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203479s021lbl.pdf
07/29/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203479s012lbl.pdf
04/14/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203479s014lbl.pdf
02/23/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203479s010lbl.pdf
09/30/2015	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf
09/15/2015	SUPPL-8	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf
09/15/2015	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf
12/05/2013	SUPPL-1	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf
12/05/2013	SUPPL-1	REMS-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf
08/22/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf
02/06/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf

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