Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078066
Company: LONG GROVE PHARMS

Products on ANDA 078066

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCITRIOL	CALCITRIOL	0.001MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes
CALCITRIOL	CALCITRIOL	0.002MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078066

CALCITRIOL

INJECTABLE;INJECTION; 0.001MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCITRIOL	CALCITRIOL	0.001MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211030	GLAND PHARMA LTD
CALCITRIOL	CALCITRIOL	0.001MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078066	LONG GROVE PHARMS