FDA.reportPublic FDA data

Application 078069

Type
ANDA
Sponsor
BRECKENRIDGE PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7262OXCARBAZEPINEOXCARBAZEPINEMajor PharmaceuticalsANDACurrent
0904-7263OXCARBAZEPINEOXCARBAZEPINEMajor PharmaceuticalsANDACurrent
0904-7264OXCARBAZEPINEOXCARBAZEPINEMajor PharmaceuticalsANDACurrent
50090-5003OXCARBAZEPINEOXCARBAZEPINEA-S Medication SolutionsANDACurrent
51991-292OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-292OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-292OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-293OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-293OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-293OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-294OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-294OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-294OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.ANDACurrent
55154-8187OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
55154-8187OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
55154-8187OxcarbazepineOxcarbazepineCardinal Health 107, LLCANDACurrent
55154-8198OxcarbazepineOxcarbazepineCardinal Health 107, LLCANDACurrent
55154-8198OxcarbazepineOxcarbazepineCardinal HealthANDACurrent
55700-868OXCARBAZEPINEOXCARBAZEPINEQuality Care Products, LLCANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical SupplyANDACurrent
60429-061OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical SupplyANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-062OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.ANDACurrent
60429-063OXCARBAZEPINEOXCARBAZEPINEGolden State Medical SupplyANDACurrent
63629-2075OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-2075OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-3816OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-3816OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-3816OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-6834OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-6834OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-6834OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
63629-9186OXCARBAZEPINEOXCARBAZEPINEBryant Ranch PrepackANDACurrent
64725-0292OXCARBAZEPINEOXCARBAZEPINETYA PharmaceuticalsANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-845OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-853OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68084-867OxcarbazepineOxcarbazepineAmerican Health PackagingANDACurrent
68788-7866OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7866OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-0894OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2253OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2254OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2254OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2254OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2276OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent
70518-2370OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22619ORIG2011-02-15
44630ORIG2008-01-17