Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071633
Company: YAOPHARMA CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLAZAMIDE TOLAZAMIDE 100MG TABLET;ORAL Discontinued None 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
12/09/1987 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
05/09/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/24/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/24/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/1992 SUPPL-7 Labeling

Label is not available on this site.

04/05/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/08/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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