Documents
Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 25MG/5ML | 1 | FLEQSUVY | BACLOFEN |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2022-02-04 | STANDARD |
Submissions Property Types
CDER Filings
AZURITY
cder:Array
(
[0] => Array
(
[ApplNo] => 215602
[companyName] => AZURITY
[docInserts] => ["",""]
[products] => [{"drugName":"FLEQSUVY","activeIngredients":"BACLOFEN","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/04\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215602s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215602s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215602Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-02-04
)
)