FDA.reportPublic FDA data

Application 206494

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVYCAZAVIBACTAM SODIUM; CEFTAZIDIMEPOWDER;IV (INFUSION)EQ 0.5GM BASE;2GM/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent
0456-2700AVYCAZceftazidime, avibactamAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82159SUPPL 2025-05-05
82142SUPPL 2025-05-05
81423SUPPL 2025-03-04
81392SUPPL 2025-03-03
77348SUPPL 2024-01-29
77323SUPPL 2024-01-29
72996SUPPL2022-12-22
72986SUPPL2022-12-21
65568SUPPL2020-12-10
65533SUPPL2020-12-09
58008SUPPL2019-03-15
58007SUPPL2019-03-15
58005SUPPL2019-03-15
58004SUPPL2019-03-15
52279SUPPL2018-02-02
52267SUPPL2018-02-02
47015SUPPL2017-01-30
46994SUPPL2017-01-26
40553SUPPL2016-06-23
32812SUPPL2016-06-23
40552SUPPL2015-09-04
32811SUPPL2015-09-04
43522ORIG2015-03-12
24517ORIG2015-03-12
40551ORIG2015-02-27
32810ORIG2015-02-27
62878SUPPL1900-01-01