FDA.reportPublic FDA data

Application 018421

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LITHIUM CITRATELITHIUM CITRATESYRUP;ORALEQ 300MG CARBONATE/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3527LithiumLithiumHikma Pharmaceuticals USA Inc.NDACurrent
0054-3527LithiumLithiumWest-Ward Pharmaceuticals CorpNDACurrent
0054-3527LithiumLithiumHikma Pharmaceuticals USA Inc.NDACurrent
0054-3527LithiumLithiumWest-Ward Pharmaceuticals CorpNDACurrent
0054-3527LithiumLithiumWest-Ward Pharmaceuticals CorpNDACurrent
0054-3527LithiumLithiumWest-Ward Pharmaceuticals CorpNDACurrent
0054-3527LithiumLithiumHikma Pharmaceuticals USA Inc.NDACurrent
68094-757LithiumLithiumPrecision Dose Inc.NDACurrent
68094-757LithiumLithiumPrecision Dose Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72385SUPPL2022-10-17
72384SUPPL2022-10-17
72330SUPPL2022-10-14
61835SUPPL2020-02-06
61834SUPPL2020-02-06
61783SUPPL2020-02-06
56998SUPPL2018-12-21
56997SUPPL2018-12-21
56956SUPPL2018-12-21
55921SUPPL2018-10-15
55918SUPPL2018-10-15
55890SUPPL2018-10-11
45759SUPPL2016-11-01
45710SUPPL2016-10-28
11213SUPPL2011-10-25
914SUPPL2011-10-25
913SUPPL2003-01-31
14998SUPPL2001-11-26
14997SUPPL2001-11-26
912SUPPL2001-11-26
911SUPPL2001-11-26
910SUPPL2001-11-26