FDA.reportPublic FDA data

Application 208653

Type
NDA
Sponsor
KVK TECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APADAZACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDETABLET;ORAL325MG;EQ 6.12MG BASEYesNo
002APADAZACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDETABLET;ORAL325MG;EQ 4.08MG BASEYesNo
003APADAZACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDETABLET;ORAL325MG;EQ 8.16MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-340APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-340APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-340APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-341APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-341APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-341APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-342APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-342APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-342APADAZBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDACurrent
10702-343Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-343Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-343Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-343Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-344Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-344Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-344Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-344Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-345Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-345Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-345Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
10702-345Benzhydrocodone and AcetaminophenBenzhydrocodone and AcetaminophenKVK-Tech, Inc.NDA AUTHORIZED GENERICCurrent
70040-0145APADAZBenzhydrocodone and AcetaminophenKemPharm, Inc.NDACurrent
70040-0167APADAZBenzhydrocodone and AcetaminophenKemPharm, Inc.NDACurrent
70040-0189APADAZBenzhydrocodone and AcetaminophenKemPharm, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80098SUPPL 2024-11-04
77058SUPPL 2023-12-19
76991SUPPL 2023-12-19
76963SUPPL 2023-12-18
76247ORIG 2023-11-03
66540SUPPL2021-03-05
66539SUPPL2021-03-05
66511SUPPL2021-03-05
60465SUPPL2019-10-09
60446SUPPL2019-10-09
60444SUPPL2019-10-09
57826ORIG2019-02-27
55712SUPPL2018-10-01
55711SUPPL2018-10-01
55519SUPPL2018-09-19
55518SUPPL2018-09-19
52722ORIG2018-02-26
52710ORIG2018-02-26