Application Sponsors
| ANDA 206953 | MAYNE PHARMA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| 002 | TABLET;SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2020-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 2022-05-03 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 11 | AP | 2022-12-16 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MAYNE PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206953
[companyName] => MAYNE PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 2MG BASE;EQ 0.5MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 8MG BASE;EQ 2MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)