Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062118
Company: FACTA FARMA
Company: FACTA FARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| CEPHALEXIN | CEPHALEXIN | 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 |
|---|---|---|---|---|---|---|---|
| 03/27/1978 | 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 |
|---|---|---|---|---|---|
| 08/27/2002 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/01/1999 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 10/01/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/24/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 04/13/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/20/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |