Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084279
Company: WATSON LABS

Products on ANDA 084279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COL-PROBENECID	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/1976	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084279_col-probenecid_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2002	SUPPL-45	Manufacturing (CMC)-Facility		Label is not available on this site.
04/25/2001	SUPPL-44	Manufacturing (CMC)-Control		Label is not available on this site.
01/28/1991	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
05/31/1991	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
11/30/1989	SUPPL-40	Labeling		Label is not available on this site.
06/29/1990	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
03/14/1988	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
03/14/1988	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
03/14/1988	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
01/22/1985	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
02/15/1984	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
11/09/1983	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/29/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
06/29/1983	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
06/29/1983	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
11/30/1982	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
01/28/1982	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084279

COL-PROBENECID

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	NOVAST LABS