NDA 208653

KVK TECH INC

FDA Drug Application

Application #208653

Documents

• Label: 2018-02-26
• Letter: 2018-02-26
• Label: 2018-09-19
• Label: 2018-09-19
• Letter: 2018-10-01
• Letter: 2018-10-01
• Review: 2019-02-27
• Label: 2019-10-09
• Medication Guide: 2019-10-09
• Letter: 2019-10-09
• Letter: 2021-03-05
• Label: 2021-03-05
• Medication Guide: 2021-03-05

Application Sponsors

NDA 208653

KVK TECH INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	325MG;EQ 6.12MG BASE	1	APADAZ	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
002	TABLET;ORAL	325MG;EQ 4.08MG BASE	1	APADAZ	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
003	TABLET;ORAL	325MG;EQ 8.16MG BASE	1	APADAZ	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2018-02-23	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2018-09-18	STANDARD
REMS; REMS	SUPPL	3	AP	2018-09-18	N/A
LABELING; Labeling	SUPPL	5	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	5	Null	7
SUPPL	7	Null	6

CDER Filings

KVK TECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208653
            [companyName] => KVK TECH INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/208653s005lbl.pdf#page=37"]
            [products] => [{"drugName":"APADAZ","activeIngredients":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","strength":"325MG;EQ 6.12MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"APADAZ","activeIngredients":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","strength":"325MG;EQ 4.08MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"APADAZ","activeIngredients":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","strength":"325MG;EQ 8.16MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208653s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208653s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208653s002s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208653s002s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208653s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208653s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208653Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208653Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208653s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208653Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208653s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208653Orig1s002s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208653s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208653Orig1s002s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-10-07
        )

)