Active substance
Doxercalciferol
- US FDA 18
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | SANDOZ | Prescription | 5 May 2014 |
| DOXERCALCIFEROL | 0.5MCG; 1MCG; 2.5MCG | capsule · oral | RISING | Prescription | 9 Sep 2016 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | GLAND | Prescription | 26 Sep 2019 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | MEITHEAL | Prescription | 7 Feb 2020 |
| DOXERCALCIFEROL | 0.5MCG; 1MCG; 2.5MCG | capsule · oral | AVET | Prescription | 15 Sep 2020 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | ALEMBIC | Prescription | 15 Jun 2023 |
| HECTOROL | 2.5MCG; 0.5MCG; 1MCG | capsule · oral | SANOFI | Discontinued | 9 Jun 1999 |
| HECTOROL | 4MCG/2ML (2MCG/ML); 2MCG/ML (2MCG/ML) | injectable · injection | SANOFI | Discontinued | 6 Apr 2000 |
| DOXERCALCIFEROL | 0.5MCG; 1MCG; 2.5MCG | capsule · oral | HIKMA PHARMS | Discontinued | 23 Sep 2011 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | HIKMA | Discontinued | 30 Aug 2013 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML); 2MCG/ML (2MCG/ML) | injectable · injection | CAPLIN | Discontinued | 4 Feb 2014 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML); 2MCG/ML (2MCG/ML) | injectable · injection | EPIC PHARMA LLC | Discontinued | 7 May 2015 |
| DOXERCALCIFEROL | 2MCG/ML (2MCG/ML); 4MCG/2ML (2MCG/ML) | injectable · injection | AMNEAL | Discontinued | 24 May 2017 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | AMNEAL | Discontinued | 24 May 2017 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML); 10MCG/5ML (2MCG/ML) | injectable · injection | HOSPIRA | Discontinued | 24 Jul 2018 |
| DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | injectable · injection | LUPIN | Discontinued | 1 Nov 2018 |
| DOXERCALCIFEROL | 2MCG/ML (2MCG/ML); 4MCG/2ML (2MCG/ML) | injectable · injection | SUN PHARM | Discontinued | 14 Nov 2019 |
| DOXERCALCIFEROL | 2MCG/ML (2MCG/ML); 4MCG/2ML (2MCG/ML) | injectable · injection | EUGIA PHARMA | Discontinued | 24 Jan 2022 |
Safety signals and safety-related labeling changes
- US FDA 11 Jun 2025 HECTOROL — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 28 Aug 2019 DOXERCALCIFEROL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations - US FDA 21 Nov 2018 HECTOROL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.