Application 213369

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL600MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75163ORIG 2023-08-21