Documents
Application Sponsors
| ANDA 077500 | SUN PHARM INDS LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 2MG;125MG | 0 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
FDA Submissions
| ORIG | 1 | AP | 2006-09-06 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-04-14 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-04-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-04-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-04-14 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-11-22 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 77500
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)