Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
09/29/1982 | 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 |
---|---|---|---|---|---|
01/08/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
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04/30/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
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10/08/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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04/14/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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01/10/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/02/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/12/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/18/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/01/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |