Lithium Carbonate Extended Release Oral Tablet

Brand(s)
Lithobid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Anip Acquisition Company (2014-06-27)
Oldest Current Product
2002-09-06
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\LITHIUM CARBONATE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\LITHIUM CARBONATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\LITHIUM CARBONATE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\LITHIUM CARBONATE
ORAL\TABLET\LITHIUM CARBONATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\LITHIUM
ORAL\TABLET, EXTENDED RELEASE\LITHIUM CATION
ORAL\TABLET, EXTENDED RELEASE\LITHIUM HYDROXIDE ANHYDROUS
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\LITHIUM CATION
ORAL\TABLET\LITHIUM CATION

product(s) by strength(s)

lithium carbonate 300 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625590280LithobidNDAAnip Acquisition Company2014-07-01LITHIUM CARBONATEORALTABLET, FILM COATED, EXTENDED RELEASENDA018027f7f5b69a-c2a1-4586-a189-1475d41387c0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540021ANDARoxane Laboratories, Inc2004-10-28LITHIUM CARBONATEORALTABLET, EXTENDED RELEASEANDA076832c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e
2003781300ANDAMylan Pharmaceuticals Inc.2012-07-25LITHIUM CARBONATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA202288785a0327-998b-4154-9461-b72cb78e2739
3510790180ANDAMylan Institutional Inc.2012-08-10LITHIUM CARBONATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA20228803685ed5-d626-472a-b268-fcb8259f5b41
4684620223ANDAGlenmark Generics Inc., Usa2010-12-27LITHIUM CARBONATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0915441b65d27e-5086-4a87-8387-c49f3d060978

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155593ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2004-10-28LITHIUM CARBONATEORALTABLET, FILM COATED, EXTENDED RELEASE000540021ANDA07683249df16d6-b5c9-422a-8676-a678b7946efc
2493490156ANDARemedyrepack Inc.2011-04-13LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE00054002125ANDA076832ed67fdb9-db87-4b9a-a588-7c26f538efab
3548685239ANDAPhysicians Total Care, Inc.2005-03-01LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540021ANDA076832722ba14f-fd79-413e-bc1d-21fc10718e90
4551544960ANDACardinal Health2004-10-28LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540021ANDA076832f1daf89a-12e0-4d68-9f04-1cb840e4aceb
5680840640ANDAAmerican Health Packaging2014-10-13LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540021ANDA0768325ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197
6681510639ANDACarilion Materials Management2004-10-28LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540021ANDA0768327f3aa4f5-908a-44e7-8113-b64f91dc86e7

lithium carbonate 450 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540020ANDARoxane Laboratories, Inc2004-01-05LITHIUM CARBONATEORALTABLET, EXTENDED RELEASEANDA076691a226a88d-eb57-4c96-afda-939801bca0a9
2003781450ANDAMylan Pharmaceuticals Inc.2012-08-09LITHIUM CARBONATEORALTABLET, EXTENDED RELEASEANDA20221952205c7d-1483-446b-aeae-47709656a4cf
3510790142ANDAMylan Institutional Inc.2012-04-20LITHIUM CARBONATEORALTABLET, EXTENDED RELEASEANDA2022191b62b9b9-a2bf-4517-99c2-a6a94f514a38
4684620224ANDAGlenmark Generics Inc., Usa2011-02-14LITHIUM CARBONATEORALTABLETANDA091616525a9d9b-cbb1-4644-a28a-8bba96f09348

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001431277ANDAWest-Ward Pharmaceutical Corp2002-09-06LITHIUM CARBONATEORALTABLET, EXTENDED RELEASEANDA0764901beeea2f-a922-43df-aa9e-2231ef404ba4
2009046204ANDAMajor2003-06-17LITHIUM CARBONATEORALTABLET, EXTENDED RELEASEANDA076490f5bb4d2c-dce3-4216-8c5e-8c7a5f48f3fb
3548685340ANDAPhysicians Total Care, Inc.2005-06-22LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE001431277ANDA076490e038fdbc-6d80-4840-afb6-032bf006913f
4551547456ANDACardinal Health2003-06-17LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE001431277ANDA076490cdb1b889-3a8a-4caf-a19d-d5c8ea578b9d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490691ANDARemedyrepack Inc.2011-05-17LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540020ANDA076691df441cd9-fc5f-4f25-998d-f7f274cff691
2581181224ANDAClinical Solutions Wholesale2015-06-08LITHIUM CARBONATEORALTABLET684620224ANDA09161622e2e677-87e6-412c-a3d6-0914fddf780f
3680840655ANDAAmerican Health Packaging2014-01-13LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540020ANDA076691d276da3c-9952-4674-a54d-b1258df71b8a
4681510245ANDACarilion Materials Management2004-01-05LITHIUM CARBONATEORALTABLET, EXTENDED RELEASE000540020ANDA0766919efc1d04-7aae-4ca9-9af6-ea6f3e095db2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076170LITHIUM CARBONATETrueBARR LABORATORIES INC2002-06-10ANDA076170_001
2ANDA076366LITHIUM CARBONATETrueBARR LABORATORIES INC2003-08-21ANDA076366_001
3ANDA076382LITHIUM CARBONATETrueABLE LABORATORIES INC2003-04-21ANDA076382_001
4ANDA076490LITHIUM CARBONATETrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC2003-06-17ANDA076490_001
5ANDA076691LITHIUM CARBONATEROXANE LABORATORIES INC2004-01-05ANDA076691_001
6ANDA076832LITHIUM CARBONATEROXANE LABORATORIES INC2004-10-28ANDA076832_001
7ANDA091544LITHIUM CARBONATEGLENMARK GENERICS LTD INDIA2010-12-27ANDA091544_001
8ANDA091616LITHIUM CARBONATEGLENMARK GENERICS LTD2011-02-14ANDA091616_001
9ANDA202219LITHIUM CARBONATEMYLAN PHARMACEUTICALS INC2012-08-08ANDA202219_001
10ANDA202288LITHIUM CARBONATEMYLAN PHARMACEUTICALS INC2012-06-29ANDA202288_001
11ANDA204445LITHIUM CARBONATEALEMBIC PHARMACEUTICALS LTD2015-06-10ANDA204445_001
12ANDA204779LITHIUM CARBONATEUNIQUE PHARMACEUTICAL LABORATORIES2015-07-27ANDA204779_001
13NDA018027LITHOBIDANI PHARMACEUTICALS INCNDA018027_001
14NDA018152ESKALITH CRTrueJDS PHARMACEUTICALS LLC1982-03-29NDA018152_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076170_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalse2002-06-10LITHIUM CARBONATE
2ANDA076366_001discontinuedLITHIUM CARBONATE (450MG)ORALTABLET, EXTENDED RELEASEFalse2003-08-21LITHIUM CARBONATE
3ANDA076382_001discontinuedLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalse2003-04-21LITHIUM CARBONATE
4ANDA076490_001discontinuedLITHIUM CARBONATE (450MG)ORALTABLET, EXTENDED RELEASEFalse2003-06-17LITHIUM CARBONATE
5ANDA076691_001RXLITHIUM CARBONATE (450MG)ORALTABLET, EXTENDED RELEASETrueAB2004-01-05LITHIUM CARBONATE
6ANDA076832_001RXLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2004-10-28LITHIUM CARBONATE
7ANDA091544_001RXLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-12-27LITHIUM CARBONATE
8ANDA091616_001RXLITHIUM CARBONATE (450MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-02-14LITHIUM CARBONATE
9ANDA202219_001RXLITHIUM CARBONATE (450MG)ORALTABLET, EXTENDED RELEASEFalseAB2012-08-08LITHIUM CARBONATE
10ANDA202288_001RXLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2012-06-29LITHIUM CARBONATE
11ANDA204445_001RXLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-06-10LITHIUM CARBONATE
12ANDA204779_001RXLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-07-27LITHIUM CARBONATE
13NDA018027_001RXLITHIUM CARBONATE (300MG)ORALTABLET, EXTENDED RELEASETrueABLITHOBID
14NDA018152_001discontinuedLITHIUM CARBONATE (450MG)ORALTABLET, EXTENDED RELEASEFalse1982-03-29ESKALITH CR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103685ed5-d626-472a-b268-fcb8259f5b41 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-11-012510790180
21b62b9b9-a2bf-4517-99c2-a6a94f514a38 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-09-062510790142
31b65d27e-5086-4a87-8387-c49f3d060978 (view SPL)Lithium Carbonate Extended-Release Tablets USP, 300 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-11-195684620223
41beeea2f-a922-43df-aa9e-2231ef404ba4 (view SPL)Lithium Carbonate Extended Release TabletsprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2013-04-104001431277
522e2e677-87e6-412c-a3d6-0914fddf780f (view SPL)LITHIUM CARBONATE Extended-Release Tablets USP, 450 mgprescriptionHuman PrescriptionClinical Solutions Wholesalerepack2015-06-082581181224
649df16d6-b5c9-422a-8676-a678b7946efc (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 300 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-06-156006155593
752205c7d-1483-446b-aeae-47709656a4cf (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-05-304003781450
8525a9d9b-cbb1-4644-a28a-8bba96f09348 (view SPL)LITHIUM CARBONATE Extended-Release Tablets USP, 450 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-11-196684620224
95ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197 (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 300 mgprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-11-111680840640
10722ba14f-fd79-413e-bc1d-21fc10718e90 (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 300 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-082548685239
11785a0327-998b-4154-9461-b72cb78e2739 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-07-254003781300
127f3aa4f5-908a-44e7-8113-b64f91dc86e7 (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 300 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-12-122681510639
139efc1d04-7aae-4ca9-9af6-ea6f3e095db2 (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 450 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-12-082681510245
14a226a88d-eb57-4c96-afda-939801bca0a9 (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 450 mgprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2011-12-085000540020
15c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 300 mgprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2011-12-127000540021
16cdb1b889-3a8a-4caf-a19d-d5c8ea578b9d (view SPL)LITHIUM CARBONATEEXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-172551547456
17d276da3c-9952-4674-a54d-b1258df71b8a (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 450 mgprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-131680840655
18df441cd9-fc5f-4f25-998d-f7f274cff691 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-05-171493490691
19e038fdbc-6d80-4840-afb6-032bf006913f (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-03-252548685340
20ea4ece7f-e81f-48de-b262-577db5b6fe6c (view SPL)LITHOBID (Lithium Carbonate, USP)Extended-Release Tablets 300 mgprescriptionHuman PrescriptionNoven Therapeutics, LlcANALYSIS, MANUFACTURE2012-02-166689684492
21ed67fdb9-db87-4b9a-a588-7c26f538efab (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-131493490156
22f1daf89a-12e0-4d68-9f04-1cb840e4aceb (view SPL)LITHIUM CARBONATE Extended Release Tablets USP, 300 mgprescriptionHuman PrescriptionCardinal HealthREPACK2013-11-054551544960
23f5bb4d2c-dce3-4216-8c5e-8c7a5f48f3fb (view SPL)LITHIUM CARBONATEEXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionMajorMANUFACTURE2010-08-131009046204
24f7f5b69a-c2a1-4586-a189-1475d41387c0 (view SPL)LITHOBID (Lithium Carbonate USP) Extended-Release Tablets 300 mgprescriptionHuman PrescriptionAnip Acquisition CompanyANALYSIS, LABEL, MANUFACTURE, PACK2014-06-271625590280

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