Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088072
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUINIDINE SULFATE | QUINIDINE SULFATE | 300MG | TABLET;ORAL | Prescription | None | No | Yes |
QUINIDINE SULFATE | QUINIDINE SULFATE | 200MG | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/26/1983 | 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 |
---|---|---|---|---|---|
02/10/2022 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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02/02/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/18/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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09/03/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/29/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/08/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/07/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |