FDA.reportPublic FDA data

Application 077272

Type
ANDA
Sponsor
TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET;ORAL100MGNoNo
002CARBAMAZEPINECARBAMAZEPINETABLET;ORAL200MGNoNo
003CARBAMAZEPINECARBAMAZEPINETABLET;ORAL300MGNoNo
004CARBAMAZEPINECARBAMAZEPINETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-4515CARBAMAZEPINECARBAMAZEPINENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6172CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
0904-6172CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
0904-6172CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
0904-6172CARBAMAZEPINECARBAMAZEPINEMajor PharmaceuticalsANDACurrent
13668-268CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-268CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-268CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-268CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
13668-268CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals LimitedANDACurrent
49999-616CARBAMAZEPINECARBAMAZEPINELake Erie Medical DBA Quality Care Products LLCANDACurrent
55154-1396CarbamazepineCarbamazepineCardinal Health 107, LLCANDACurrent
55154-1396CarbamazepineCarbamazepineCardinal HealthANDACurrent
55154-1396CarbamazepineCarbamazepineCardinal HealthANDACurrent
58118-0268CARBAMAZEPINECARBAMAZEPINEClinical Solutions WholesaleANDACurrent
58118-0268CARBAMAZEPINECARBAMAZEPINEClinical Solutions WholesaleANDACurrent
58118-0268CARBAMAZEPINECARBAMAZEPINEClinical Solutions WholesaleANDACurrent
60687-490CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
66267-278CARBAMAZEPINECARBAMAZEPINENuCare Pharmaceuticals, Inc.ANDACurrent
66267-278CARBAMAZEPINECARBAMAZEPINENuCare Pharmaceuticals, Inc.ANDACurrent
67046-096CARBAMAZEPINECARBAMAZEPINEContract Pharmacy Services-PAANDACurrent
68788-9492CARBAMAZEPINECARBAMAZEPINEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9492CARBAMAZEPINECARBAMAZEPINEPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0902CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0902CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0902CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0902CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0902CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0902CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2456CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2456CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2456CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2456CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2489CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2489CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2489CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2489CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2489CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
71335-0462CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent
71335-0462CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent
71335-0462CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent
71335-0462CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent
71335-0462CARBAMAZEPINECARBAMAZEPINEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44618ORIG2008-02-01