ANDA 200343

VISTAPHARM

FDA Drug Application

Application #200343

Application Sponsors

ANDA 200343

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

325MG/15ML;7.5MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-01-25
LABELING; Labeling	SUPPL	2	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	4	AP	2018-09-18
LABELING; Labeling	SUPPL	5	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	11	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200343
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG\/15ML;7.5MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/25\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-4","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-03-04
        )

)