Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208614
Company: HOSPIRA INC
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 203929 AKORN INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 208974 AMNEAL
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 208975 AMNEAL
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 PHARMS
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription Yes AP 208614 HOSPIRA INC
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 091333 SANDOZ INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 200926 SANDOZ INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 203875 SUN PHARM
HECTOROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription Yes AP 021027 SANOFI

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