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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208614
Company: HOSPIRA

Products on NDA 208614

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208614

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

Labels for NDA 208614

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

Therapeutic Equivalents for NDA 208614

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	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

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