Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | 1 | ACETAMINOPHEN | ACETAMINOPHEN |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2022-06-03 | STANDARD |
Submissions Property Types
CDER Filings
INNOPHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 206968
[companyName] => INNOPHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/03\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206968s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206968s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/206968Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-06-03
)
)