Application 022152

Type
NDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STAVZORVALPROIC ACIDCAPSULE, DELAYED RELEASE;ORAL125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002STAVZORVALPROIC ACIDCAPSULE, DELAYED RELEASE;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003STAVZORVALPROIC ACIDCAPSULE, DELAYED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85663SUPPL 2026-04-10
85629SUPPL 2026-04-02
85618SUPPL 2026-04-02
69433SUPPL2021-12-01
69432SUPPL2021-12-01
69431SUPPL2021-12-01
61499SUPPL2020-01-02
61469SUPPL2019-12-30
17022SUPPL2014-09-03
6971SUPPL2014-09-03
38312SUPPL2014-03-10
6970SUPPL2014-03-10
17021SUPPL2013-06-18
6969SUPPL2013-06-18
17020SUPPL2013-03-01
17019SUPPL2013-03-01
29326SUPPL2013-02-28
6968SUPPL2013-02-28
44684ORIG2009-08-25
21946ORIG2009-08-25
38311SUPPL2009-05-12
29325SUPPL2009-05-04
29324SUPPL2009-02-06
38310ORIG2008-08-07
6967ORIG2008-07-31