Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089894
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUINIDINE GLUCONATE | QUINIDINE GLUCONATE | 324MG | 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 |
---|---|---|---|---|---|---|---|
12/15/1988 | 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 |
---|---|---|---|---|---|
05/09/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/29/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/29/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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04/06/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/02/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |