FDA.reportPublic FDA data

Application 209377

Type
NDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZINC SULFATEZINC SULFATESOLUTION;INTRAVENOUSEQ 30MG BASE/10ML (EQ 3MG BASE/ML)YesYes
002ZINC SULFATEZINC SULFATESOLUTION;INTRAVENOUSEQ 25MG BASE/5ML (EQ 5MG BASE/ML)YesYes
003ZINC SULFATEZINC SULFATESOLUTION;INTRAVENOUSEQ 10MG BASE/10ML (EQ 1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-6101Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-6101Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-6103Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-6103Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-6103Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-6103Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-8005Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-8005Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-8005Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent
0517-8005Zinc SulfateZinc SulfateAmerican Regent, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65126SUPPL2020-11-02
65081SUPPL2020-10-30
60164ORIG2019-09-30
59387ORIG2019-07-19
59377ORIG2019-07-19
63286ORIG1900-01-01
63267ORIG1900-01-01