FDA.reportPublic FDA data

Application 212102

Type
NDA
Sponsor
ZOGENIX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINTEPLAFENFLUAMINESOLUTION; ORAL2.5MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43376-322FINTEPLAFenfluramineZogenix, Inc.NDACurrent
43376-322FINTEPLAFenfluramineZogenix, Inc.NDACurrent
43376-322FINTEPLAFenfluramineZogenix, Inc.NDACurrent
43376-322FINTEPLAFenfluramineZogenix, Inc.NDACurrent
43376-322FINTEPLAFenfluramineZogenix, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83794SUPPL 2025-10-16
83793SUPPL 2025-10-16
83791SUPPL 2025-10-16
81917SUPPL 2025-04-09
81904SUPPL 2025-04-09
78042SUPPL 2024-04-03
76775SUPPL 2023-12-12
76769SUPPL 2023-12-12
76360ORIG 2023-11-06
75487SUPPL 2023-09-15
75486SUPPL 2023-09-15
75476SUPPL 2023-09-15
75475SUPPL 2023-09-15
74411SUPPL 2023-05-31
73087SUPPL2023-01-04
73086SUPPL2023-01-04
73083SUPPL2023-01-04
71362SUPPL2022-06-21
71353SUPPL2022-06-21
71338SUPPL2022-06-16
70629SUPPL2022-03-28
70622SUPPL2022-03-28
70621SUPPL2022-03-28
65530ORIG2020-12-08
63745ORIG2020-06-29
63743ORIG2020-06-26
63711ORIG2020-06-26