Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087011
Company: DAVA PHARMS INC
Company: DAVA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINIDINE SULFATE | QUINIDINE SULFATE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1979 | 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 |
|---|---|---|---|---|---|
| 02/25/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/08/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/13/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |