Application Sponsors
NDA 018621 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5MG/ML | 0 | NITRO-BID | NITROGLYCERIN |
FDA Submissions
| ORIG | 1 | AP | 1982-01-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-06-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1987-12-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-09-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1989-09-21 | |
LABELING; Labeling | SUPPL | 10 | AP | 1989-09-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1989-09-21 | |
LABELING; Labeling | SUPPL | 13 | AP | 1992-11-18 | |
LABELING; Labeling | SUPPL | 14 | AP | 1993-06-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1994-11-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1995-06-22 | |
LABELING; Labeling | SUPPL | 18 | AP | 1996-07-11 | |
LABELING; Labeling | SUPPL | 19 | AP | 1996-11-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1997-12-15 | |
LABELING; Labeling | SUPPL | 21 | AP | 1997-09-29 | |
Submissions Property Types
ORIG | 1 | 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 | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 18621
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)