Application Sponsors
| ANDA 201720 | SUN PHARM INDS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG/ML | 0 | TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE |
| 002 | INJECTABLE;INJECTION | 200MG/ML | 0 | TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-06-03 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-05-11 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2016-10-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-10-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AO |
| 002 | Prescription | AO |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201720
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/25\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/14\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/25\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/11\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/19\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-10-25
)
)