Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
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 |
---|---|---|---|---|---|---|---|
08/04/1986 | 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-21 | Labeling-Package Insert |
Label is not available on this site. |
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02/08/2021 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/06/2019 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/01/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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12/23/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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09/17/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/07/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/22/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/08/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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11/13/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/13/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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11/13/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |