Application Sponsors
| ANDA 211785 | MYLAN TECHNOLOGIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FILM;BUCCAL, SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| 002 | FILM;BUCCAL, SUBLINGUAL | EQ 4MG BASE;EQ 1MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2020-04-17 | STANDARD |
| REMS; REMS | SUPPL | 2 | AP | 2022-05-03 | |
| REMS; REMS | SUPPL | 5 | AP | 2022-12-16 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN TECHNOLOGIES
cder:Array
(
[0] => Array
(
[ApplNo] => 211785
[companyName] => MYLAN TECHNOLOGIES
[docInserts] => ["",""]
[products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 4MG BASE;EQ 1MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-04-17
)
)