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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213717
Company: EUGIA PHARMA

Products on ANDA 213717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXERCALCIFEROL	DOXERCALCIFEROL	2MCG/ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213717

DOXERCALCIFEROL

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

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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