Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201518
Company: RISING

Products on ANDA 201518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXERCALCIFEROL	DOXERCALCIFEROL	0.5MCG	CAPSULE;ORAL	Prescription	AB	No	No
DOXERCALCIFEROL	DOXERCALCIFEROL	1MCG	CAPSULE;ORAL	Prescription	AB	No	No
DOXERCALCIFEROL	DOXERCALCIFEROL	2.5MCG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2016	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 201518

DOXERCALCIFEROL

CAPSULE;ORAL; 0.5MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXERCALCIFEROL	DOXERCALCIFEROL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	205360	AVET
DOXERCALCIFEROL	DOXERCALCIFEROL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	201518	RISING
HECTOROL	DOXERCALCIFEROL	0.5MCG	CAPSULE;ORAL	Prescription	Yes	AB	020862	SANOFI

CAPSULE;ORAL; 1MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXERCALCIFEROL	DOXERCALCIFEROL	1MCG	CAPSULE;ORAL	Prescription	No	AB	205360	AVET
DOXERCALCIFEROL	DOXERCALCIFEROL	1MCG	CAPSULE;ORAL	Prescription	No	AB	201518	RISING
HECTOROL	DOXERCALCIFEROL	1MCG	CAPSULE;ORAL	Prescription	Yes	AB	020862	SANOFI

CAPSULE;ORAL; 2.5MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXERCALCIFEROL	DOXERCALCIFEROL	2.5MCG	CAPSULE;ORAL	Prescription	No	AB	205360	AVET
DOXERCALCIFEROL	DOXERCALCIFEROL	2.5MCG	CAPSULE;ORAL	Prescription	No	AB	201518	RISING
HECTOROL	DOXERCALCIFEROL	2.5MCG	CAPSULE;ORAL	Prescription	Yes	AB	020862	SANOFI