ANDA 202142

MIKART INC

FDA Drug Application

Application #202142

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 202142

MIKART INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

300MG/5ML;10MG/5ML

0

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2018-11-27
LABELING; Labeling	SUPPL	2	AP	2019-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2020-05-29	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15

CDER Filings

MIKART INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202142
            [companyName] => MIKART INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"300MG\/5ML;10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202142Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/08\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-29
        )

)