Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 15MG | 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. |
||
02/08/2021 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
10/01/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
11/19/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/29/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/26/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/06/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
08/18/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
07/30/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |