Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MCG/HR | 0 | BUPRENORPHINE | BUPRENORPHINE |
002 | FILM, EXTENDED RELEASE;TRANSDERMAL | 7.5MCG/HR | 0 | BUPRENORPHINE | BUPRENORPHINE |
003 | FILM, EXTENDED RELEASE;TRANSDERMAL | 10MCG/HR | 0 | BUPRENORPHINE | BUPRENORPHINE |
004 | FILM, EXTENDED RELEASE;TRANSDERMAL | 15MCG/HR | 0 | BUPRENORPHINE | BUPRENORPHINE |
005 | FILM, EXTENDED RELEASE;TRANSDERMAL | 20MCG/HR | 0 | BUPRENORPHINE | BUPRENORPHINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-09-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
CDER Filings
AVEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 210272
[companyName] => AVEVA
[docInserts] => ["",""]
[products] => [{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"7.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"10MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"15MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE","activeIngredients":"BUPRENORPHINE","strength":"20MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-09-23
)
)