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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040618
Company: INGENUS PHARMS LLC

Products on ANDA 040618

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROBENECID AND COLCHICINE	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040618

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/2008	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 040618

PROBENECID AND COLCHICINE

TABLET;ORAL; 0.5MG;500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COL-PROBENECID	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET;ORAL	Prescription	Yes	AB	084279	WATSON LABS
PROBENECID AND COLCHICINE	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET;ORAL	Prescription	No	AB	040618	INGENUS PHARMS LLC
PROBENECID AND COLCHICINE	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET;ORAL	Prescription	No	AB	217030	RISING

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