Application Sponsors
Marketing Status
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
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
)
)