Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040045
Company: COSETTE PHARMS NC
Company: COSETTE PHARMS NC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINIDINE SULFATE | QUINIDINE SULFATE | 300MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/30/1994 | 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 |
|---|---|---|---|---|---|
| 10/03/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |