Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013378
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYMELOR ACETOHEXAMIDE 500MG TABLET;ORAL Discontinued None No No
DYMELOR ACETOHEXAMIDE 250MG 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
12/23/1964 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/16/1998 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1990 SUPPL-30 Labeling

Label is not available on this site.

12/29/1988 SUPPL-29 Labeling

Label is not available on this site.

01/30/1987 SUPPL-28 Labeling

Label is not available on this site.

09/15/1986 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1986 SUPPL-26 Labeling

Label is not available on this site.

03/18/1986 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1985 SUPPL-24 Labeling

Label is not available on this site.

01/31/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1980 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/23/1981 SUPPL-18 Labeling

Label is not available on this site.

03/21/1980 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/27/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1979 SUPPL-15 Labeling

Label is not available on this site.

09/15/1976 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

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