FDA.reportPublic FDA data

Application 018558

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LITHIUM CARBONATELITHIUM CARBONATETABLET;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-4527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-4527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-4527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-4527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-4527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-4527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-4527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8528Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8528Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8528Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8528Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8528Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8528Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8528Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8528Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
70518-0150Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
72789-174Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.NDACurrent
72789-174Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72387SUPPL2022-10-17
72386SUPPL2022-10-17
72342SUPPL2022-10-14
61837SUPPL2020-02-06
61836SUPPL2020-02-06
61784SUPPL2020-02-06
57000SUPPL2018-12-21
56999SUPPL2018-12-21
56957SUPPL2018-12-21
55920SUPPL2018-10-15
55919SUPPL2018-10-15
55891SUPPL2018-10-11
45758SUPPL2016-11-01
45711SUPPL2016-10-28