Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070259
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLAZAMIDE TOLAZAMIDE 250MG TABLET;ORAL Prescription None No No
TOLAZAMIDE TOLAZAMIDE 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
11/07/1986 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
03/10/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

11/20/2009 SUPPL-22 Labeling

Label is not available on this site.

01/10/2002 SUPPL-16 Labeling

Label is not available on this site.

03/10/2000 SUPPL-15 Labeling

Label is not available on this site.

09/20/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/15/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-8 Labeling

Label is not available on this site.

02/05/1991 SUPPL-7 Labeling

Label is not available on this site.

01/31/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/27/1989 SUPPL-5 Labeling

Label is not available on this site.

03/21/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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