Application 213586

Type
NDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS50MG/0.14ML (50MG/0.14ML)YesYes
002UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS75MG/0.21ML (75MG/0.21ML)YesYes
003UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS100MG/0.28ML (100MG/0.28ML)YesYes
004UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS125MG/0.35ML (125MG/0.35ML)YesYes
005UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS150MG/0.42ML (150MG/0.42ML)YesYes
006UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS200MG/0.56ML (200MG/0.56ML)YesYes
007UZEDYRISPERIDONESUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS250MG/0.7ML (250MG/0.7ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83761SUPPL 2025-10-15
83760SUPPL 2025-10-15
83728SUPPL 2025-10-14
83727SUPPL 2025-10-14
81160SUPPL 2025-02-07
80948SUPPL 2025-02-05
77723ORIG 2024-03-06
76035SUPPL 2023-11-02
74127ORIG 2023-05-01
74121ORIG 2023-05-01