Application Sponsors
| ANDA 208162 | STRIDES PHARMA | |
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 | 2016-05-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-07-30 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-08-19 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 208162
[companyName] => STRIDES PHARMA
[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":"05\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/30\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-30
)
)