FDA.reportPublic FDA data

Application 208171

Type
NDA
Sponsor
PHARMACOSMOS AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONOFERRICFERRIC DERISOMALTOSESOLUTION;INTRAVENOUS100MG/ML (100MG/ML)YesYes
002MONOFERRICFERRIC DERISOMALTOSESOLUTION;INTRAVENOUS500MG/5ML (100MG/ML)YesYes
003MONOFERRICFERRIC DERISOMALTOSESOLUTION;INTRAVENOUS1GM/10ML (100MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49442-9301MonoferricFerric derisomaltosePharmacosmos A/SNDACurrent
49442-9305MonoferricFerric derisomaltosePharmacosmos A/SNDACurrent
49442-9310MonoferricFerric derisomaltosePharmacosmos A/SNDACurrent
73594-9301MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9301MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9301MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9301MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9301MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9301MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9305MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9305MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9305MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9305MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9305MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9305MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9310MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9310MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9310MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9310MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9310MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent
73594-9310MonoferricFerric derisomaltosePharmacosmos Therapeutics Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79299SUPPL 2024-08-02
79288SUPPL 2024-08-02
71732SUPPL2022-08-05
71725SUPPL2022-08-05
64618SUPPL2020-09-21
64573SUPPL2020-09-14
62846ORIG2020-05-07
61600ORIG2020-01-17
61586ORIG2020-01-16