Carbamazepine Chewable Tablet

Brand(s)
Tegretol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-08-28)
Oldest Current Product
1981-12-14
License(s)
NDA, ANDA
RxNORM
CHEWABLE TABLET\CARBAMAZEPINE
FDAOB
ORAL\TABLET, CHEWABLE\CARBAMAZEPINE
ORAL\TABLET\CARBAMAZEPINE
SPL Active
ORAL\TABLET, CHEWABLE\CARBAMAZEPINE
ORAL\TABLET\CARBAMAZEPINE
SPL Moiety
ORAL\TABLET, CHEWABLE\CARBAMAZEPINE
ORAL\TABLET\CARBAMAZEPINE

product(s) by strength(s)

carbamazepine 100 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780492TegretolNDANovartis Pharmaceuticals Corporation1981-12-142014-10-31CARBAMAZEPINEORALTABLET, CHEWABLENDA0182818d409411-aa9f-4f3a-a52c-fbcb0c3ec053

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930778ANDATeva Pharmaceuticals Usa Inc1995-09-18CARBAMAZEPINEORALTABLET, CHEWABLEANDA073524bfd63965-56e6-4af7-b7ef-45a5105d4d35
2009043854ANDAMajor2010-03-22CARBAMAZEPINEORALTABLET, CHEWABLEANDA0757122a8c7366-ce89-47ce-8123-96f26812fca0
3516724041ANDATaro Pharmaceuticals U.S.A., Inc.2000-10-24CARBAMAZEPINEORALTABLET, CHEWABLEANDA0756870526a054-3eda-49b4-b390-7d5d16e30af8

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154515ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2005-12-07CARBAMAZEPINEORALTABLET136680271ANDA077272fd97d064-4c55-481d-b7ef-cfb948fc75b4
2493490001ANDARemedyrepack Inc.2011-08-17CARBAMAZEPINEORALTABLET, CHEWABLE516724041ANDA075687c8c74af4-cac5-4cde-ab68-3f3647c5cb99
3493490694ANDARemedyrepack Inc.2011-07-13CARBAMAZEPINEORALTABLET, CHEWABLE136680271ANDA0757122139632a-49b6-44cc-b01d-97f6c293e237
4510790870ANDAMylan Institutional Inc.1996-05-15CARBAMAZEPINEORALTABLET, CHEWABLE000930778ANDA073524ccb97a82-315f-4a23-b98f-37d3a63ac381
5538080858ANDAState Of Florida Doh Central Pharmacy2013-01-01CARBAMAZEPINEORALTABLET, CHEWABLE136680271ANDA0757121d6698da-dacd-44e3-8af1-976bc7427de1
6548682462ANDAPhysicians Total Care, Inc.1995-07-27CARBAMAZEPINEORALTABLET, CHEWABLE000930778ANDA073524f38feadf-3fa4-430c-99ed-374023f8132c
7551543030ANDACardinal Health2000-10-24CARBAMAZEPINEORALTABLET, CHEWABLE516724041ANDA075687435bf032-e65f-4fb1-94b9-66b9727c3cdd
8551545086ANDACardinal Health2011-10-28CARBAMAZEPINEORALTABLET, CHEWABLE510790870ANDA0735248e9e18aa-6c9d-4172-87b4-4bec6f485cb9
9581181271ANDAClinical Solutions Wholesale2009-08-26CARBAMAZEPINEORALTABLET, CHEWABLE136680271ANDA075712e36ece79-544b-43b2-8cf9-ca9861b071b5
10604290934ANDAGolden State Medical Supply, Inc.2000-10-24CARBAMAZEPINEORALTABLET, CHEWABLE516724041ANDA075687536811ab-308b-4866-9185-9e4149483512
11762370127ANDAMckesson Contract Packaging2011-09-01CARBAMAZEPINEORALTABLET, CHEWABLE136680271ANDA0757126fca30bd-28e5-4e32-b194-97c84966900d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490565ANDARemedyrepack Inc.2013-03-01CARBAMAZEPINEORALTABLET, CHEWABLE516724005ANDA0756871fd37534-5afd-4e9d-ad19-6a4b4a4a483f
2687889812ANDAPreferred Pharmaceuticals, Inc.2012-04-23CARBAMAZEPINEORALTABLET, CHEWABLE516724050ANDA075687157f67bd-74f0-4d68-9058-8fa707c564be

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070231CARBAMAZEPINETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1986-08-14ANDA070231_001Carbamazepine Oral Tablet
2ANDA070300CARBAMAZEPINETrueUSL PHARMA INC1986-05-15ANDA070300_001Carbamazepine Oral Tablet
3ANDA070429CARBAMAZEPINETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1987-01-02ANDA070429_001Carbamazepine Oral Tablet
4ANDA070541EPITOLTEVA PHARMACEUTICALS USA INC1986-09-17ANDA070541_001Carbamazepine Oral Tablet
5ANDA071479CARBAMAZEPINETruePLIVA INC1987-07-24ANDA071479_001Carbamazepine Oral Tablet
6ANDA071696CARBAMAZEPINETrueACTAVIS ELIZABETH LLC1987-11-09ANDA071696_001Carbamazepine Oral Tablet
7ANDA071940CARBAMAZEPINETrueJUBILANT CADISTA PHARMACEUTICALS INC1988-02-01ANDA071940_001
8ANDA073524EPITOLTEVA PHARMACEUTICALS USA INC1992-07-29ANDA073524_001
9ANDA074649CARBAMAZEPINETARO PHARMACEUTICAL INDUSTRIES LTD1996-10-03ANDA074649_001Carbamazepine Oral Tablet
10ANDA075687CARBAMAZEPINETARO PHARMACEUTICAL INDUSTRIES LTD2000-10-24ANDA075687_001, ANDA075687_002
11ANDA075712CARBAMAZEPINETORRENT PHARMACEUTICALS LTD2001-07-05ANDA075712_001
12ANDA075948CARBAMAZEPINEAPOTEX INC ETOBICOKE SITE2002-02-27ANDA075948_001Carbamazepine Oral Tablet
13ANDA076525TERILTrueTARO PHARMACEUTICAL INDUSTRIES LTD2003-09-26ANDA076525_001Carbamazepine Oral Tablet
14ANDA077272CARBAMAZEPINETORRENT PHARMACEUTICALS LTD2005-12-07ANDA077272_001, ANDA077272_002, ANDA077272_003, ANDA077272_004Carbamazepine Oral Tablet
15NDA016608TEGRETOLNOVARTIS PHARMACEUTICALS CORPNDA016608_001Carbamazepine Oral Tablet
16NDA018281TEGRETOLNOVARTIS PHARMACEUTICALS CORPNDA018281_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070231_001discontinuedCARBAMAZEPINE (200MG)ORALTABLETFalse1986-08-14CARBAMAZEPINE
2ANDA070300_001discontinuedCARBAMAZEPINE (200MG)ORALTABLETFalse1986-05-15CARBAMAZEPINE
3ANDA070429_001discontinuedCARBAMAZEPINE (200MG)ORALTABLETFalse1987-01-02CARBAMAZEPINE
4ANDA070541_001RXCARBAMAZEPINE (200MG)ORALTABLETFalseAB1986-09-17EPITOL
5ANDA071479_001discontinuedCARBAMAZEPINE (200MG)ORALTABLETFalse1987-07-24CARBAMAZEPINE
6ANDA071696_001discontinuedCARBAMAZEPINE (200MG)ORALTABLETFalse1987-11-09CARBAMAZEPINE
7ANDA071940_001discontinuedCARBAMAZEPINE (100MG)ORALTABLET, CHEWABLEFalse1988-02-01CARBAMAZEPINE
8ANDA073524_001RXCARBAMAZEPINE (100MG)ORALTABLET, CHEWABLEFalseAB1992-07-29EPITOL
9ANDA074649_001RXCARBAMAZEPINE (200MG)ORALTABLETFalseAB1996-10-03CARBAMAZEPINE
10ANDA075687_001RXCARBAMAZEPINE (100MG)ORALTABLET, CHEWABLEFalseAB2000-10-24CARBAMAZEPINE
11ANDA075687_002RXCARBAMAZEPINE (200MG)ORALTABLET, CHEWABLETrue2002-07-29CARBAMAZEPINE
12ANDA075712_001RXCARBAMAZEPINE (100MG)ORALTABLET, CHEWABLEFalseAB2001-07-05CARBAMAZEPINE
13ANDA075948_001RXCARBAMAZEPINE (200MG)ORALTABLETFalseAB2002-02-27CARBAMAZEPINE
14ANDA076525_001discontinuedCARBAMAZEPINE (200MG)ORALTABLETFalse2003-09-26TERIL
15ANDA077272_001RXCARBAMAZEPINE (100MG)ORALTABLETFalse2005-12-07CARBAMAZEPINE
16ANDA077272_002RXCARBAMAZEPINE (200MG)ORALTABLETFalseAB2005-12-07CARBAMAZEPINE
17ANDA077272_003RXCARBAMAZEPINE (300MG)ORALTABLETFalse2005-12-07CARBAMAZEPINE
18ANDA077272_004RXCARBAMAZEPINE (400MG)ORALTABLETFalse2005-12-07CARBAMAZEPINE
19NDA016608_001RXCARBAMAZEPINE (200MG)ORALTABLETTrueABTEGRETOL
20NDA018281_001RXCARBAMAZEPINE (100MG)ORALTABLET, CHEWABLETrueABTEGRETOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10526a054-3eda-49b4-b390-7d5d16e30af8 (view SPL)Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mLprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.API MANUFACTURE, MANUFACTURE2015-09-105516724041, 516724005, 516724047, 516724123, 516724124, 516724125Carbamazepine Oral Suspension
Carbamazepine Oral Tablet
Carbamazepine Extended Release Oral Tablet
2157f67bd-74f0-4d68-9058-8fa707c564be (view SPL)Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mLprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-04-023687889812
31d6698da-dacd-44e3-8af1-976bc7427de1 (view SPL)Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mgprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-03-072538080858
41fd37534-5afd-4e9d-ad19-6a4b4a4a483f (view SPL)Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mLprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-011493490565
52139632a-49b6-44cc-b01d-97f6c293e237 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-131493490694
62a8c7366-ce89-47ce-8123-96f26812fca0 (view SPL)Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mgprescriptionHuman PrescriptionMajor2013-08-2012009043854, 009046172Carbamazepine Oral Tablet
7435bf032-e65f-4fb1-94b9-66b9727c3cdd (view SPL)Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mLprescriptionHuman PrescriptionCardinal HealthREPACK2015-05-066551543030, 551543029Carbamazepine Oral Tablet
8536811ab-308b-4866-9185-9e4149483512 (view SPL)CARBAMAZEPINE, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290934, 604290120, 604290932Carbamazepine Oral Suspension
Carbamazepine Oral Tablet
96fca30bd-28e5-4e32-b194-97c84966900d (view SPL)Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mgprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2011-09-011762370127
108d409411-aa9f-4f3a-a52c-fbcb0c3ec053 (view SPL)TegretolprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-08-2818000780492, 000780508, 000780509, 000780510, 000780511, 000780512Carbamazepine Oral Suspension
Carbamazepine Oral Tablet
Carbamazepine Extended Release Oral Tablet
118e9e18aa-6c9d-4172-87b4-4bec6f485cb9 (view SPL)CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE TABLETS, USP (CHEWABLE), 100 mgRx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2012-03-271551545086
12bfd63965-56e6-4af7-b7ef-45a5105d4d35 (view SPL)CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE TABLETS USP (CHEWABLE), 100 mg 0109 0778 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-10-0216000930778, 000930109Carbamazepine Oral Tablet
13c8c74af4-cac5-4cde-ab68-3f3647c5cb99 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-1710493490001
14ccb97a82-315f-4a23-b98f-37d3a63ac381 (view SPL)CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE TABLETS USP (CHEWABLE), 100 mg Rx onlyprescriptionHuman PrescriptionMylan Institutional Inc.2015-03-067510790870, 510790385Carbamazepine Oral Tablet
15e36ece79-544b-43b2-8cf9-ca9861b071b5 (view SPL)Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mgprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581181271, 581180268Carbamazepine Oral Tablet
16f38feadf-3fa4-430c-99ed-374023f8132c (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-102548682462, 548680147Carbamazepine Oral Tablet
17fd97d064-4c55-481d-b7ef-cfb948fc75b4 (view SPL)Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-03-156006154515

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