Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064148
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/23/1996 | 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 |
|---|---|---|---|---|---|
| 08/04/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/04/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/26/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/10/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |