FDA.reportPublic FDA data

Application 216249

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZINC SULFATEZINC SULFATESOLUTION;INTRAVENOUSEQ 25MG BASE/5ML (EQ 5MG BASE/ML)NoNo
002ZINC SULFATEZINC SULFATESOLUTION;INTRAVENOUSEQ 30MG BASE/10ML (EQ 3MG BASE/ML)NoNo
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
66794-239Zinc SulfateZinc SulfatePiramal Critical Care Inc.ANDACurrent
66794-239Zinc SulfateZinc SulfatePiramal Critical Care Inc.ANDACurrent
66794-240Zinc SulfateZinc SulfatePiramal Critical Care Inc.ANDACurrent
66794-240Zinc SulfateZinc SulfatePiramal Critical Care Inc.ANDACurrent
68083-498Zinc SulfateZinc SulfateGland Pharma LimitedANDACurrent
68083-499Zinc SulfateZinc SulfateGland Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71886ORIG2022-08-25