Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084442
Company: WATSON LABS TEVA

Products on ANDA 084442

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/02/1977	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
04/29/2002	SUPPL-51	Manufacturing (CMC)-Facility		Label is not available on this site.
04/25/2001	SUPPL-50	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/2000	SUPPL-49	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/1993	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
04/17/1989	SUPPL-41	Labeling		Label is not available on this site.
11/15/1988	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
11/15/1988	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
06/03/1985	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
06/03/1985	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
01/15/1985	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
02/16/1984	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
03/29/1983	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
03/29/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084442

PROBENECID

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