Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083862
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
09/02/1976 | 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 |
---|---|---|---|---|---|
01/07/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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02/01/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/08/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/08/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/09/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |