FDA.reportPublic FDA data

Application 020458

Type
NDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALZINZINC ACETATECAPSULE;ORALEQ 25MG ZINCYesNo
002GALZINZINC ACETATECAPSULE;ORALEQ 50MG ZINCYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57844-208GALZINZinc AcetateTeva Select BrandsNDACurrent
57844-208GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-208GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-208GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-208GALZINZinc AcetateTeva Select BrandsNDACurrent
57844-208GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-208GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-208GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-215GALZINZinc AcetateTeva Select BrandsNDACurrent
57844-215GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-215GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-215GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-215GALZINZinc AcetateTeva Select BrandsNDACurrent
57844-215GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-215GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent
57844-215GALZINZinc AcetateTeva Pharmaceuticals USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78293SUPPL 2024-04-29
78271SUPPL 2024-04-26
24998SUPPL2002-03-14
20667ORIG1997-01-28