Lithium Carbonate Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-03-10)
Oldest Current Product
1982-01-29
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\LITHIUM CARBONATE
FDAOB
ORAL\TABLET\LITHIUM CARBONATE
SPL Active
ORAL\TABLET\LITHIUM CARBONATE
SPL Moiety
ORAL\TABLET\LITHIUM CATION

product(s) by strength(s)

lithium carbonate 300 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544527NDARoxane Laboratories, Inc1982-01-29LITHIUM CARBONATEORALTABLETNDA0185587dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1627560430ANDASun Pharmaceutical Industries Limited2010-07-08LITHIUM CARBONATEORALTABLETANDA091027d3284649-ed4c-4096-987b-4ac16b8278f2

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431300ANDAWest-Ward Pharmaceutical Corp2010-12-28LITHIUM CARBONATEORALTABLETANDA078715283d1332-9670-48c8-89bc-2a51634bd89a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900781NDAStat Rx Usa Llc1982-01-29LITHIUM CARBONATEORALTABLET000544527NDA01855875a54819-053b-4347-8b14-7b9ccc575042
2521250282NDARemedyrepack Inc.2013-05-07LITHIUM CARBONATEORALTABLET000544527NDA0185585c54e60e-24ac-4fbb-bc99-523bf59362fb
3551544941NDACardinal Health1982-01-29LITHIUM CARBONATEORALTABLET000548528NDA0185580e6b0a2d-b79c-44d8-b785-5267df9e8f72

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078715LITHIUM CARBONATETrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC2010-12-28ANDA078715_001
2ANDA091027LITHIUM CARBONATESUN PHARMACEUTICAL INDUSTRIES INC2010-06-24ANDA091027_001
3NDA016834LITHIUM CARBONATETruePFIZER INCNDA016834_001
4NDA016980LITHOTABSTrueSOLVAY PHARMACEUTICALSNDA016980_001
5NDA017971ESKALITHTrueJDS PHARMACEUTICALS LLCNDA017971_001
6NDA018558LITHIUM CARBONATEROXANE LABORATORIES INC1982-01-29NDA018558_001
7NDA018833LITHANETrueBAYER PHARMACEUTICALS CORP1985-07-18NDA018833_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078715_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLETFalse2010-12-28LITHIUM CARBONATE
2ANDA091027_001RXLITHIUM CARBONATE (300MG)ORALTABLETFalseAB2010-06-24LITHIUM CARBONATE
3NDA016834_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLETFalseLITHIUM CARBONATE
4NDA016980_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLETFalseLITHOTABS
5NDA017971_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLETFalseESKALITH
6NDA018558_001RXLITHIUM CARBONATE (300MG)ORALTABLETTrueAB1982-01-29LITHIUM CARBONATE
7NDA018833_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLETFalse1985-07-18LITHANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10e6b0a2d-b79c-44d8-b785-5267df9e8f72 (view SPL)LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-183551544941, 551544920, 551544952lithium citrate Oral Solution
Lithium Carbonate Oral Capsule
2283d1332-9670-48c8-89bc-2a51634bd89a (view SPL)Lithium Carbonate Tablets, USPRx OnlyRev. 12/11prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-12-204001431300
35c54e60e-24ac-4fbb-bc99-523bf59362fb (view SPL)LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-071521250282
475a54819-053b-4347-8b14-7b9ccc575042 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2009-04-091165900781
57dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e (view SPL)LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-03-1011000544527, 000542526, 000542527, 000542531, 000543527, 000548526, 000548527, 000548528, 000548529, 000548531lithium citrate Oral Solution
Lithium Carbonate Oral Capsule
6d3284649-ed4c-4096-987b-4ac16b8278f2 (view SPL)Lithium Carbonate Tablets USPprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-05-142627560430

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII