Documents
Application Sponsors
| NDA 022534 | SUN PHARMA GLOBAL | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | INJECTABLE;INJECTION | 20MG/VIAL | 1 | DOCEFREZ | DOCETAXEL |
| 002 | INJECTABLE;INJECTION | 80MG/VIAL | 1 | DOCEFREZ | DOCETAXEL |
| 003 | SOLUTION;INTRAVENOUS | 20MG/ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
| 004 | SOLUTION;INTRAVENOUS | 80MG/4ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
| 005 | SOLUTION;INTRAVENOUS | 160MG/8ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2011-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-07-13 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2013-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-10-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-02-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-05-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2019-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2022-12-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 16 | Null | 6 |
TE Codes
| 003 | Prescription | AP |
| 004 | Prescription | AP |
| 005 | Prescription | AP |
CDER Filings
SUN PHARMA GLOBAL
cder:Array
(
[0] => Array
(
[ApplNo] => 22534
[companyName] => SUN PHARMA GLOBAL
[docInserts] => ["",""]
[products] => [{"drugName":"DOCEFREZ","activeIngredients":"DOCETAXEL","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DOCEFREZ","activeIngredients":"DOCETAXEL","strength":"80MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/01\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022534s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022534s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022534s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022534s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022534s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022534s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022534s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DOCEFREZ","submission":"DOCETAXEL","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DOCEFREZ","submission":"DOCETAXEL","actionType":"80MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"20MG\/ML (20MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"80MG\/4ML (20MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"160MG\/8ML (20MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2021-02-01
)
)