Documents
Application Sponsors
| ANDA 205299 | DR REDDYS LABS SA | |
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 8MG BASE;EQ 2MG BASE | 0 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-06-14 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 2022-05-03 | |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-12-06 | STANDARD |
| REMS; REMS | SUPPL | 14 | AP | 2022-12-16 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 9 | Null | 4 |
| SUPPL | 12 | Null | 4 |
| SUPPL | 14 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
DR REDDYS LABS SA
cder:Array
(
[0] => Array
(
[ApplNo] => 205299
[companyName] => DR REDDYS LABS SA
[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 8MG BASE;EQ 2MG BASE","dosageForm":"FILM;BUCCAL, SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"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\\\/205299Orig1s000ltr.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
)
)