Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070303
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/20/1985 | 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 |
|---|---|---|---|---|---|
| 05/09/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/08/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/23/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |