Application Sponsors
| ANDA 209226 | STRIDES PHARMA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 30MG BASE | 0 | CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 60MG BASE | 0 | CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE |
| 003 | TABLET;ORAL | EQ 90MG BASE | 0 | CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-05-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 209226
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"EQ 90MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/18\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-18
)
)