Drugs@FDA: FDA-Approved Drugs
Company: SANOFI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HECTOROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
HECTOROL | DOXERCALCIFEROL | 2MCG/ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/06/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21027_Hectorol.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/28/2022 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021027Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021027Orig1s038ltr.pdf | |
11/21/2018 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020862s031,021027s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020862Orig1s031,021027Orig1s034ltr.pdf | |
12/15/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/24/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/2013 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/01/2016 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021027Orig1s026ltr.pdf | |
12/15/2010 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/05/2008 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021027s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021027Orig1s015.pdf | |
07/20/2006 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021027s013,020862s019ltr.pdf | |
06/22/2005 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021027s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021027s012ltr.pdf | |
11/26/2003 | SUPPL-7 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21027scm007ltr.pdf |
11/19/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/24/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/03/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/26/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/28/2022 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021027Orig1s038lbl.pdf | |
11/21/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020862s031,021027s034lbl.pdf | |
06/01/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf | |
12/05/2008 | SUPPL-15 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf | |
07/20/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf | |
06/22/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021027s012lbl.pdf | |
04/06/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21027lbl.pdf |
HECTOROL
INJECTABLE;INJECTION; 4MCG/2ML (2MCG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215810 | ALEMBIC |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208975 | AMNEAL |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213717 | EUGIA PHARMA |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210452 | GLAND PHARMA LTD |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091101 | HIKMA |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 208614 | HOSPIRA |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210801 | LUPIN LTD |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 211670 | MEITHEAL |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091333 | SANDOZ |
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200926 | SANDOZ |
HECTOROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 021027 | SANOFI |
INJECTABLE;INJECTION; 2MCG/ML (2MCG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 2MCG/ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213717 | EUGIA PHARMA |
HECTOROL | DOXERCALCIFEROL | 2MCG/ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 021027 | SANOFI |