Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086445
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLBUTAMIDE TOLBUTAMIDE 500MG TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/10/1979 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
11/12/2009 SUPPL-63 Labeling

Label is not available on this site.

09/27/2001 SUPPL-59 Labeling

Label is not available on this site.

02/05/1998 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

11/03/1993 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

01/23/1991 SUPPL-54 Labeling

Label is not available on this site.

01/31/1990 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

08/08/1989 SUPPL-52 Labeling

Label is not available on this site.

08/28/1987 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

09/18/1984 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/18/1982 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

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