Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208614
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
DOXERCALCIFEROL | DOXERCALCIFEROL | 10MCG/5ML (2MCG/ML) | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
07/24/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208614s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208614Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208614Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/28/2019 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208614s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208614Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/28/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208614s002lbl.pdf | |
07/24/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208614s000lbl.pdf |
DOXERCALCIFEROL
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 | 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 |