Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064061
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 04/27/1995 | 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 |
|---|---|---|---|---|---|
| 08/20/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |