Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085583
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINIDINE SULFATE | QUINIDINE SULFATE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/09/1981 | 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 |
|---|---|---|---|---|---|
| 04/25/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 09/15/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 01/09/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |