Documents
Application Sponsors
NDA 018733 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | TALWIN NX | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1982-12-16 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1983-04-05 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1983-04-05 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1983-04-05 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1983-04-05 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1983-04-05 | PRIORITY |
LABELING; Labeling | SUPPL | 7 | AP | 1989-01-12 | PRIORITY |
LABELING; Labeling | SUPPL | 8 | AP | 1985-10-09 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1987-02-02 | PRIORITY |
LABELING; Labeling | SUPPL | 10 | AP | 1989-01-12 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-02-29 | PRIORITY |
LABELING; Labeling | SUPPL | 12 | AP | 2003-02-26 | PRIORITY |
LABELING; Labeling | SUPPL | 14 | AP | 2008-09-01 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 2011-02-24 | PRIORITY |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 18733
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"TALWIN NX","activeIngredients":"NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE","strength":"EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/24\/2011","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018733s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018733s014lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TALWIN NX","submission":"NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2011-02-24
)
)