Application Sponsors
| ANDA 077851 | NATCO PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 4MG BASE | 0 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 8MG BASE | 0 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2007-06-25 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-02-14 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
NATCO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 77851
[companyName] => NATCO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)