Application Sponsors
| ANDA 203458 | UNICHEM LABS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG | 0 | METRONIDAZOLE | METRONIDAZOLE |
| 002 | TABLET;ORAL | 500MG | 0 | METRONIDAZOLE | METRONIDAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-01-22 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-03-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203458
[companyName] => UNICHEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/14\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-08-14
)
)