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Application 209112

Type
NDA
Sponsor
MCGUFF

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASCORASCORBIC ACIDSOLUTION;INTRAVENOUS25,000MG/50ML (500MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent
67157-101AscorAscorbic AcidMcGuff Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80171SUPPL 2024-11-05
80170SUPPL 2024-11-05
80165SUPPL 2024-11-05
77302SUPPL 2024-01-25
77301SUPPL 2024-01-25
71543SUPPL2022-07-13
71532SUPPL2022-07-11
52670ORIG2018-02-20
49937ORIG2017-10-04
49935ORIG2017-10-03