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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022152
Company: BIONPHARMA

Medication Guide

Summary Review

Products on NDA 022152

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STAVZOR	VALPROIC ACID	125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
STAVZOR	VALPROIC ACID	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
STAVZOR	VALPROIC ACID	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022152

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2008	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/2008/022152lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022152s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022152_stavzor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022152s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022152s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022152Orig1s009ltr.pdf
12/26/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022152s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022152Orig1s008ltr.pdf
08/28/2014	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s007ltr.pdf
03/07/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s006ltr.pdf
06/14/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s005ltr.pdf
02/26/2013	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004ltr.pdf
02/26/2013	SUPPL-3	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004ltr.pdf
04/23/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022152s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s002ltr.pdf
02/04/2009	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s001ltr.pdf

Labels for NDA 022152

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022152s009lbl.pdf
12/26/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022152s008lbl.pdf
08/28/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s007lbl.pdf
03/07/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s006lbl.pdf
06/14/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s005lbl.pdf
02/26/2013	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf
02/26/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf
02/26/2013	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf
02/26/2013	SUPPL-3	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf
04/23/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022152s002lbl.pdf
07/29/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022152lbl.pdf

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