FDA.reportPublic FDA data

Application 017812

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LITHIUM CARBONATELITHIUM CARBONATECAPSULE;ORAL300MGYesNo
002LITHIUM CARBONATELITHIUM CARBONATECAPSULE;ORAL150MGYesNo
003LITHIUM CARBONATELITHIUM CARBONATECAPSULE;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-2526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-2531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-2531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8526Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8526Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8527Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8527Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8531Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals CorpNDACurrent
0054-8531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0054-8531Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.NDACurrent
0615-1311Lithium CarbonateLithium CarbonateNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
0615-2304Lithium CarbonateLithium CarbonateNCS HealthCare of KY, Inc dba Vangard LabsNDACurrent
50090-1722Lithium CarbonateLithium CarbonateA-S Medication SolutionsNDACurrent
50090-2799Lithium CarbonateLithium CarbonateA-S Medication SolutionsNDACurrent
50090-2799Lithium CarbonateLithium CarbonateA-S Medication SolutionsNDACurrent
50090-2799Lithium CarbonateLithium CarbonateA-S Medication SolutionsNDACurrent
50090-2959Lithium CarbonateLithium CarbonateA-S Medication SolutionsNDACurrent
50090-2959Lithium CarbonateLithium CarbonateA-S Medication SolutionsNDACurrent
53808-0705Lithium CarbonateLithium CarbonateState of Florida DOH Central PharmacyNDACurrent
55154-4920Lithium CarbonateLithium CarbonateCardinal Health 107, LLCNDACurrent
55154-4920Lithium CarbonateLithium CarbonateCardinal HealthNDACurrent
55154-4920Lithium CarbonateLithium CarbonateCardinal HealthNDACurrent
55154-4920Lithium CarbonateLithium CarbonateCardinal HealthNDACurrent
64725-2527Lithium CarbonateLithium CarbonateTYA PharmaceuticalsNDACurrent
67046-397Lithium CarbonateLithium CarbonateContract Pharmacy Services-PANDACurrent
67046-430Lithium CarbonateLithium CarbonateContract Pharmacy Services-PANDACurrent
67544-534Lithium CarbonateLithium CarbonateAphena Pharma Solutions - Tennessee, Inc.NDACurrent
67544-946Lithium CarbonateLithium CarbonateAphena Pharma Solutions - Tennessee, Inc.NDACurrent
70518-1434Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-1434Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-1434Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-1434Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-1434Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-1481Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-1481Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-2345Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-2345Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-2345Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-2345Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-2345Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
70518-2345Lithium CarbonateLithium CarbonateREMEDYREPACK INC.NDACurrent
72789-172Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72383SUPPL2022-10-17
72382SUPPL2022-10-17
72341SUPPL2022-10-14
61833SUPPL2020-02-06
61832SUPPL2020-02-06
61782SUPPL2020-02-06
56996SUPPL2018-12-21
56995SUPPL2018-12-21
56955SUPPL2018-12-21
55922SUPPL2018-10-15
55917SUPPL2018-10-15
55889SUPPL2018-10-11
45760SUPPL2016-11-01
45709SUPPL2016-10-28
33350SUPPL2011-10-25
13908SUPPL2011-10-25
711SUPPL2003-01-31
13907SUPPL2001-11-26
13906SUPPL2001-11-26
13905SUPPL2001-11-26
13904SUPPL2001-11-26
709SUPPL2001-11-26
710SUPPL2001-06-14