Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072551
Company: YAOPHARMA CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLOL MALEATE TIMOLOL MALEATE 10MG 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
04/13/1989 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
12/13/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/14/1997 SUPPL-6 Labeling

Label is not available on this site.

11/18/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/17/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/05/1993 SUPPL-3 Labeling

Label is not available on this site.

07/27/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/28/1992 SUPPL-1 Labeling

Label is not available on this site.

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