FDA.reportPublic FDA data

Application 212320

Type
NDA
Sponsor
SHIELD TX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACCRUFERFERRIC MALTOLCAPSULE;ORAL30MG IRONYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent
73059-001ACCRUFERFerric MaltolShield TX (UK) LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84512SUPPL 2025-12-23
84481SUPPL 2025-12-22
72061SUPPL2022-09-10
72052SUPPL2022-09-09
71214SUPPL2022-06-06
71202SUPPL2022-06-02
70183SUPPL2022-02-17
70181SUPPL2022-02-17
65123SUPPL2020-11-02
65075SUPPL2020-10-29
59700ORIG2019-08-14
59454ORIG2019-07-26
59453ORIG2019-07-26