Carbamazepine Oral Suspension

Brand(s)
Tegretol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-08-28)
Oldest Current Product
1987-12-18
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\CARBAMAZEPINE
FDAOB
ORAL\SUSPENSION\CARBAMAZEPINE
SPL Active
ORAL\SUSPENSION\CARBAMAZEPINE
SPL Moiety
ORAL\SUSPENSION\CARBAMAZEPINE

product(s) by strength(s)

carbamazepine 20 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780508TegretolNDANovartis Pharmaceuticals Corporation1987-12-18CARBAMAZEPINEORALSUSPENSIONNDA0189278d409411-aa9f-4f3a-a52c-fbcb0c3ec053

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724047ANDATaro Pharmaceuticals U.S.A., Inc.2004-09-20CARBAMAZEPINEORALSUSPENSIONANDA0767290526a054-3eda-49b4-b390-7d5d16e30af8
2604320129ANDAMorton Grove Pharmaceuticals, Inc.2002-06-05CARBAMAZEPINEORALSUSPENSIONANDA07571499e20867-a5eb-4474-b846-619ee45f40b8

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290120ANDAGolden State Medical Supply, Inc.2004-09-20CARBAMAZEPINEORALSUSPENSION516724047ANDA076729536811ab-308b-4866-9185-9e4149483512
2680940214ANDAPrecision Dose Inc.2003-09-02CARBAMAZEPINEORALSUSPENSION516724047ANDA076729e5160019-ccdb-46d5-8510-6ea7084ca854
3680940301ANDAPrecision Dose Inc.2007-02-27CARBAMAZEPINEORALSUSPENSION516724047ANDA076729e5160019-ccdb-46d5-8510-6ea7084ca854

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075714CARBAMAZEPINEWOCKHARDT EU OPERATIONS (SWISS) AG2002-06-05ANDA075714_001
2ANDA075875CARBAMAZEPINETrueTARO PHARMACEUTICAL INDUSTRIES LTD2000-12-21ANDA075875_001
3ANDA076729TERILTARO PHARMACEUTICALS USA INC2004-09-20ANDA076729_001
4NDA018927TEGRETOLNOVARTIS PHARMACEUTICALS CORP1987-12-18NDA018927_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075714_001RXCARBAMAZEPINE (100MG/5ML)ORALSUSPENSIONFalseAB2002-06-05CARBAMAZEPINE
2ANDA075875_001discontinuedCARBAMAZEPINE (100MG/5ML)ORALSUSPENSIONFalse2000-12-21CARBAMAZEPINE
3ANDA076729_001RXCARBAMAZEPINE (100MG/5ML)ORALSUSPENSIONFalseAB2004-09-20TERIL
4NDA018927_001RXCARBAMAZEPINE (100MG/5ML)ORALSUSPENSIONTrueAB1987-12-18TEGRETOL

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, MANUFACTURE2015-09-105516724047, 516724005, 516724041, 516724123, 516724124, 516724125Carbamazepine Chewable Tablet
Carbamazepine Oral Tablet
Carbamazepine Extended Release Oral Tablet
2536811ab-308b-4866-9185-9e4149483512 (view SPL)CARBAMAZEPINE, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290120, 604290932, 604290934Carbamazepine Chewable Tablet
Carbamazepine Oral Tablet
38d409411-aa9f-4f3a-a52c-fbcb0c3ec053 (view SPL)TegretolprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-08-2818000780508, 000780492, 000780509, 000780510, 000780511, 000780512Carbamazepine Chewable Tablet
Carbamazepine Oral Tablet
Carbamazepine Extended Release Oral Tablet
499e20867-a5eb-4474-b846-619ee45f40b8 (view SPL)CARBAMAZEPINE - carbamazepine suspensionprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-12-169604320129
5e5160019-ccdb-46d5-8510-6ea7084ca854 (view SPL)CARBAMAZEPINE ORAL SUSPENSION USP 200 mg/10 mL 100 mg/5 mLprescriptionHuman PrescriptionPrecision Dose Inc.2012-02-172680940214, 680940301

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