Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013378
Company: LILLY
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. |
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| 06/16/1998 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/27/1990 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 12/29/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 01/30/1987 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 09/15/1986 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/02/1986 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 03/18/1986 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/14/1985 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/31/1983 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/14/1980 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 02/23/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/21/1980 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1979 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/09/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/15/1976 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/21/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |