Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083347
Company: IMPAX LABS
Company: IMPAX LABS
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 |
---|---|---|---|---|---|---|---|
12/08/1976 | 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 |
---|---|---|---|---|---|
02/28/1990 | SUPPL-30 | Labeling |
Label is not available on this site. |
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02/28/1990 | SUPPL-29 | Labeling |
Label is not available on this site. |
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12/23/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
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11/23/1988 | SUPPL-27 | Labeling |
Label is not available on this site. |
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02/21/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |