Application 217439

Type
NDA
Sponsor
PFIZER

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TALZENNATALAZOPARIB TOSYLATECAPSULE;ORALEQ 0.1MG BASEYesNo
002TALZENNATALAZOPARIB TOSYLATECAPSULE;ORALEQ 0.25MG BASEYesNo
003TALZENNATALAZOPARIB TOSYLATECAPSULE;ORALEQ 0.35MG BASEYesNo
004TALZENNATALAZOPARIB TOSYLATECAPSULE;ORALEQ 0.5MG BASEYesNo
005TALZENNATALAZOPARIB TOSYLATECAPSULE;ORALEQ 0.75MG BASEYesNo
006TALZENNATALAZOPARIB TOSYLATECAPSULE;ORALEQ 1MG BASEYesYes

Documents

DocumentSubmission typeDate
82571SUPPL 2025-06-13
82562SUPPL 2025-06-13
79802ORIG 2024-10-03
77769ORIG 2024-03-08
77762ORIG 2024-03-08