Documents
Application Sponsors
ANDA 202801 | HETERO LABS LTD V | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 250MG | 0 | LEVOFLOXACIN | LEVOFLOXACIN |
002 | TABLET;ORAL | 500MG | 0 | LEVOFLOXACIN | LEVOFLOXACIN |
003 | TABLET;ORAL | 750MG | 0 | LEVOFLOXACIN | LEVOFLOXACIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-01-08 | |
LABELING; Labeling | SUPPL | 3 | AP | 2019-04-24 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2019-04-24 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2019-05-03 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2022-09-27 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 13 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 202801
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202801Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-03
)
)