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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090455
Company: ONESOURCE SPECIALTY

Products on ANDA 090455

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090455

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090455

ERGOCALCIFEROL

CAPSULE;ORAL; 50,000 IU
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DRISDOL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	Yes	AA	003444	ESJAY PHARMA
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	040833	CHARTWELL RX
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	090455	ONESOURCE SPECIALTY
ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	204276	PURACAP PHARM LLC
VITAMIN D	ERGOCALCIFEROL	50,000 IU	CAPSULE;ORAL	Prescription	No	AA	080704	BIONPHARMA

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