Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084631
Company: SANDOZ
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|---|---|
| 11/24/1976 | 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 |
|---|---|---|---|---|---|
| 02/02/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/18/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 09/03/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 10/29/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/28/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/28/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/12/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/25/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/25/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |