Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007529
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINIDINE GLUCONATE | QUINIDINE GLUCONATE | 80MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/12/1950 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 03/09/2016 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2014 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/15/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 03/29/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/20/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 03/07/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/06/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 06/12/1991 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
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| 07/10/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/10/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/10/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |