Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE; ORAL | 112.5MG | 0 | VENBYSI XR | VENLAFAXINE BESYLATE |
FDA Submissions
TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage Form | ORIG | 1 | AP | 2022-06-29 | STANDARD |
TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage Form | ORIG | 2 | AP | 2022-06-29 | STANDARD |
Submissions Property Types
CDER Filings
ALMATICA
cder:Array
(
[0] => Array
(
[ApplNo] => 215429
[companyName] => ALMATICA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/215429s000lbl.pdf#page=31"]
[products] => [{"drugName":"VENBYSI XR","activeIngredients":"VENLAFAXINE BESYLATE","strength":"112.5MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/29\/2022","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/29\/2022","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient and Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215429Orig1s000,215429Orig2s000ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient and Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215429Orig1s000,215429Orig2s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-06-29
)
)