Application Sponsors
| ANDA 210327 | SHILPA MEDICARE LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
| 002 | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
| 003 | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-09-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
| 003 | Prescription | AP |
CDER Filings
SHILPA MEDICARE LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210327
[companyName] => SHILPA MEDICARE LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-05-16
)
)