Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071591
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| LORAZEPAM | LORAZEPAM | 1MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/13/1987 | 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 |
|---|---|---|---|---|---|
| 02/05/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 05/31/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |