Documents
Application Sponsors
| ANDA 207607 | MYLAN TECHNOLOGIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FILM;BUCCAL, SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| 002 | FILM;BUCCAL, SUBLINGUAL | EQ 12MG BASE;EQ 3MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-06-14 | STANDARD |
| UNKNOWN; | ORIG | 2 | AP | 2018-06-14 | STANDARD |
| REMS; REMS | SUPPL | 12 | AP | 2022-05-03 | |
| REMS; REMS | SUPPL | 15 | AP | 2022-12-16 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| ORIG | 2 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN TECHNOLOGIES
cder:Array
(
[0] => Array
(
[ApplNo] => 207607
[companyName] => MYLAN TECHNOLOGIES
[docInserts] => ["",""]
[products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG 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 12MG BASE;EQ 3MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/14\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207607Orig1s001ltr_2.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207607Orig1s000Ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/31\/2018","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-10-31
)
)