FDA.reportPublic FDA data

Application 022562

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAGLUCARGLUMIC ACIDTABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent
52276-312CarbagluCarglumic AcidOrphan Europe, SARLNDACurrent
52276-312CarbagluCarglumic AcidOrphan Europe, SARLNDACurrent
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent
52276-312CarbagluCarglumic AcidRecordati Rare DiseasesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77267SUPPL 2024-01-23
77252SUPPL 2024-01-22
68313SUPPL2021-08-06
68301SUPPL2021-08-06
66012SUPPL2021-01-28
66011SUPPL2021-01-28
65967SUPPL2021-01-25
65966SUPPL2021-01-25
64425SUPPL2020-08-27
61490SUPPL2019-12-31
61457SUPPL2019-12-26
50449SUPPL2017-11-17
50437SUPPL2017-11-17
29860SUPPL2013-08-06
38840SUPPL2013-08-05
22057ORIG2010-04-20
29859ORIG2010-03-22
38839ORIG2010-03-18