Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080084
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFADIAZINE | SULFADIAZINE | 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 |
|---|---|---|---|---|---|---|---|
| 07/05/1978 | 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 |
|---|---|---|---|---|---|
| 08/10/2000 | SUPPL-18 | Bioequivalence |
Label is not available on this site. |
||
| 04/22/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/08/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/06/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |