Application Sponsors
ANDA 088451 | WOCKHARDT BIO AG | |
Marketing Status
Application Products
001 | LOTION;TOPICAL | 0.1% | 0 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-05-29 | |
LABELING; Labeling | SUPPL | 6 | AP | 1990-01-25 | |
LABELING; Labeling | SUPPL | 7 | AP | 1992-03-12 | |
LABELING; Labeling | SUPPL | 8 | AP | 1993-12-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-08-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-08-01 | |
LABELING; Labeling | SUPPL | 11 | AP | 1996-08-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-11-10 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 13 | Null | 0 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 88451
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)