Documents
Application Sponsors
| ANDA 205022 | LANNETT CO 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 | 2016-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-02-01 | STANDARD |
| REMS; REMS | SUPPL | 4 | AP | 2018-10-31 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-11-24 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 13 | AP | 2022-05-03 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-06-17 | STANDARD |
| REMS; REMS | SUPPL | 15 | AP | 2022-12-16 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205022
[companyName] => LANNETT CO 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":"09\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205022Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/08\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2018","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/23\/2017","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-08
)
)