FDA.reportPublic FDA data

Application 209935

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KISQALI FEMARA CO-PACK (COPACKAGED)LETROZOLE; RIBOCICLIB SUCCINATETABLET, TABLET;ORAL2.5MG,N/A;N/A,EQ 200MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0909KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0916KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent
0078-0923KISQALI FEMARA CO-PACKletrozole and ribociclibNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84363SUPPL 2025-12-08
84345SUPPL 2025-12-01
82979SUPPL 2025-07-29
82970SUPPL 2025-07-29
81285SUPPL 2025-02-19
81226SUPPL 2025-02-12
80224SUPPL 2024-11-20
79999SUPPL 2024-10-25
79892SUPPL 2024-10-15
79886SUPPL 2024-10-15
79657SUPPL 2024-09-19
75306SUPPL 2023-08-29
75295SUPPL 2023-08-25
72264SUPPL2022-10-07
72238SUPPL2022-10-04
71141SUPPL2022-05-25
71140SUPPL2022-05-25
69592SUPPL2021-12-16
69530SUPPL2021-12-13
68645SUPPL2021-09-20
68632SUPPL2021-09-17
63816SUPPL2020-07-07
63814SUPPL2020-07-07
61617SUPPL2020-01-22
61613SUPPL2020-01-22
59976SUPPL2019-09-11
59969SUPPL2019-09-11
57606SUPPL2019-02-14
57591SUPPL2019-02-14
53815SUPPL2018-04-24
53798SUPPL2018-04-24
49520ORIG2017-08-23
48296ORIG2017-05-09
48246ORIG2017-05-05