Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080140
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LANIAZID | ISONIAZID | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| LANIAZID | ISONIAZID | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1975 | 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 |
|---|---|---|---|---|---|
| 02/05/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/09/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |