Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084211
Company: MYLAN
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
01/13/1976 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
02/25/1998 SUPPL-151 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-149 Labeling

Label is not available on this site.

04/24/1996 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

08/30/1994 SUPPL-147 Manufacturing (CMC)

Label is not available on this site.

04/20/1990 SUPPL-145 Labeling

Label is not available on this site.

01/31/1990 SUPPL-144 Manufacturing (CMC)

Label is not available on this site.

01/12/1990 SUPPL-143 Labeling

Label is not available on this site.

05/18/1989 SUPPL-142 Labeling

Label is not available on this site.

04/26/1988 SUPPL-141 Labeling

Label is not available on this site.

01/15/1988 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-138 Manufacturing (CMC)

Label is not available on this site.

11/15/1984 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

10/22/1984 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-134 Manufacturing (CMC)

Label is not available on this site.

03/30/1983 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-132 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-131 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

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