Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 30MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
12/08/1986 | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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02/08/2021 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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02/22/2019 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/18/2016 | SUPPL-28 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/11/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
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08/20/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
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11/30/2000 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/07/1999 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/01/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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05/06/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
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01/31/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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07/12/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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04/28/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/28/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/22/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/22/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/22/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/22/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/12/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/12/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |