Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089776
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LANIAZID | ISONIAZID | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/1988 | 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 |
|---|---|---|---|---|---|
| 11/21/2001 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/21/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 11/21/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/21/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/14/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/11/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/11/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |