FDA.reportPublic FDA data

Application 125553

Type
BLA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZARXIOFILGRASTIM-SNDZINJECTABLE;INJECTION300 mcg/0.5 mLNoNo
002ZARXIOFILGRASTIM-SNDZINJECTABLE;INJECTION480 mcg/0.8 mLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-304ZARXIOfilgrastim-sndzSandoz IncBLACurrent
61314-304ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-304ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-312ZARXIOfilgrastim-sndzSandoz IncBLACurrent
61314-312ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-312ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85716SUPPL 2026-04-20
85713SUPPL 2026-04-20
83204SUPPL 2025-08-26
83172SUPPL 2025-08-22
79968SUPPL 2024-10-23
79962SUPPL 2024-10-23
79372SUPPL 2024-08-12
79368SUPPL 2024-08-12
77250SUPPL 2024-02-06
77270SUPPL 2024-01-23
68204SUPPL2021-07-27
68196SUPPL2021-07-27
59566SUPPL2019-08-02
59550SUPPL2019-08-02
47295SUPPL2017-02-23
47271SUPPL2017-02-21
18934SUPPL2016-03-04
9783SUPPL2016-03-04
44818ORIG2015-04-20
22823ORIG2015-04-20
77403ORIG 2015-03-06
39990ORIG2015-03-06
9782ORIG2015-03-06
54061ORIG1900-01-01
51105ORIG1900-01-01
51104ORIG1900-01-01
51103ORIG1900-01-01
51102ORIG1900-01-01
51100ORIG1900-01-01