Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 4MCG/2ML (2MCG/ML) | 1 | HECTOROL | DOXERCALCIFEROL |
| 002 | INJECTABLE;INJECTION | 2MCG/ML (2MCG/ML) | 1 | HECTOROL | DOXERCALCIFEROL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-04-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-07-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-11-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2003-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2005-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2006-07-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2008-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2010-12-15 | N/A |
| LABELING; Labeling | SUPPL | 26 | AP | 2016-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2013-09-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2013-12-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2014-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2014-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2018-11-21 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2022-09-28 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 21 | Null | 31 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 38 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SANOFI
cder:Array
(
[0] => Array
(
[ApplNo] => 21027
[companyName] => SANOFI
[docInserts] => ["",""]
[products] => [{"drugName":"HECTOROL","activeIngredients":"DOXERCALCIFEROL","strength":"4MCG\/2ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"HECTOROL","activeIngredients":"DOXERCALCIFEROL","strength":"2MCG\/ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/21\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020862s031,021027s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021027s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2008","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021027s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2006","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020862s019,021027s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2005","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021027s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21027lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HECTOROL","submission":"DOXERCALCIFEROL","actionType":"4MCG\/2ML (2MCG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"HECTOROL","submission":"DOXERCALCIFEROL","actionType":"2MCG\/ML (2MCG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-11-21
)
)