Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084442
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROBENECID PROBENECID 500MG TABLET;ORAL Prescription AB No No
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.

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 084211 MYLAN
PROBENECID PROBENECID 500MG TABLET;ORAL Prescription No AB 084442 WATSON LABS TEVA

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