Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080966
Company: LANNETT

Products on ANDA 080966

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080966

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1976	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
05/15/2006	SUPPL-23	Labeling		Label is not available on this site.
08/18/1989	SUPPL-18	Labeling		Label is not available on this site.
03/11/1988	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080966

PROBALAN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROBALAN	PROBENECID	500MG	TABLET;ORAL	Prescription	No	AB	080966	LANNETT
PROBENECID	PROBENECID	500MG	TABLET;ORAL	Prescription	No	AB	217020	RISING
PROBENECID	PROBENECID	500MG	TABLET;ORAL	Prescription	No	AB	084442	WATSON LABS TEVA