Documents
Application Sponsors
| ANDA 202489 | UNIQUE PHARM LABS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG | 0 | TINIDAZOLE | TINIDAZOLE |
| 002 | TABLET;ORAL | 500MG | 0 | TINIDAZOLE | TINIDAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-10-09 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-05-26 | STANDARD |
Submissions Property Types
| SUPPL | 0 | Null | 0 |
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 202489
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"TINIDAZOLE","activeIngredients":"TINIDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TINIDAZOLE","activeIngredients":"TINIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/09\/2013","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202489Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/09\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2013","submission":"SUPPL-1","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202489Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202489Orig1s000ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-26
)
)