FDA.reportPublic FDA data

Application 076832

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LITHIUM CARBONATELITHIUM CARBONATETABLET, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0021Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0021Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0021Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0021Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0021Lithium CarbonateLithium CarbonateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0021Lithium CarbonateLithium CarbonateHikma Pharmaceuticals USA Inc.ANDACurrent
0615-5593Lithium CarbonateLithium CarbonateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
68084-640Lithium CarbonateLithium CarbonateAmerican Health PackagingANDACurrent
68084-640Lithium CarbonateLithium CarbonateAmerican Health PackagingANDACurrent
68084-640Lithium CarbonateLithium CarbonateAmerican Health PackagingANDACurrent
68084-640Lithium CarbonateLithium CarbonateAmerican Health PackagingANDACurrent
68084-640Lithium CarbonateLithium CarbonateAmerican Health PackagingANDACurrent
68151-0639Lithium CarbonateLithium CarbonateCarilion Materials ManagementANDACurrent
72789-171Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-171Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-171Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-171Lithium CarbonateLithium CarbonatePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22592ORIG2011-12-16