Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | CAPSULE, DELAYED RELEASE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | STAVZOR | VALPROIC ACID |
| 002 | CAPSULE, DELAYED RELEASE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | STAVZOR | VALPROIC ACID |
| 003 | CAPSULE, DELAYED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | STAVZOR | VALPROIC ACID |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2008-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 3 | AP | 2013-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2013-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2014-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-12-26 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-11-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 33 |
| SUPPL | 9 | Null | 6 |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22152
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"STAVZOR","activeIngredients":"VALPROIC ACID","strength":"125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"STAVZOR","activeIngredients":"VALPROIC ACID","strength":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"STAVZOR","activeIngredients":"VALPROIC ACID","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/26\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022152s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022152s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022152s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022152s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022152s003s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022152s003s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2013","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022152s003s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2013","submission":"SUPPL-3","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022152s003s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022152s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022152lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"STAVZOR","submission":"VALPROIC ACID","actionType":"125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"STAVZOR","submission":"VALPROIC ACID","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"STAVZOR","submission":"VALPROIC ACID","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-12-26
)
)