Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071068
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 |
|---|---|---|---|---|---|---|---|
| 11/25/1986 | 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-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 02/08/2021 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 10/01/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/19/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/18/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/30/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |