Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086574
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLBUTAMIDE | TOLBUTAMIDE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/04/1980 | 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-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/23/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/17/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/27/1986 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/15/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |