Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083640
Company: CYCLE
Company: CYCLE
| 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 |
|---|---|---|---|---|---|---|---|
| 07/15/1975 | 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 |
|---|---|---|---|---|---|
| 07/15/1996 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/09/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/30/1990 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/30/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/25/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |