Application Sponsors
| ANDA 065319 | WOCKHARDT BIO AG | |
Marketing Status
Application Products
| 002 | FOR SUSPENSION;ORAL | 400MG/5ML | 0 | AMOXICILLIN | AMOXICILLIN |
FDA Submissions
| ORIG | 1 | AP | 2007-06-18 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-01-14 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 65319
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)