Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022152
Company: BIONPHARMA INC
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STAVZOR VALPROIC ACID 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, DELAYED RELEASE;ORAL Discontinued None Yes No
STAVZOR VALPROIC ACID 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, DELAYED RELEASE;ORAL Discontinued None Yes No
STAVZOR VALPROIC ACID 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, DELAYED RELEASE;ORAL Discontinued None Yes No
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
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-Package Insert, Labeling-Medication Guide 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 REMS-Proposal, Labeling 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.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-3 REMS-Proposal 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
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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