Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065057
Company: WORLD GEN
Company: WORLD GEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/05/2001 | 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 |
|---|---|---|---|---|---|
| 06/18/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/07/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |