Documents
Application Sponsors
NDA 018458 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | TABLET;ORAL | 650MG;EQ 25MG BASE | 0 | TALACEN | ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1982-09-23 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 1984-06-26 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1985-05-07 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1985-10-25 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 1987-03-27 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 1987-05-22 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 1988-11-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-03-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-03-30 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2000-10-31 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2003-07-10 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2008-08-07 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2011-03-10 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2011-06-22 | STANDARD |
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 | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 18458
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"TALACEN","activeIngredients":"ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE","strength":"650MG;EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/22\/2011","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018458s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2011","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018458s014lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TALACEN","submission":"ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE","actionType":"650MG;EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2011-06-22
)
)