Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 02/13/1987 | 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 |
|---|---|---|---|---|---|
| 08/21/2012 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/22/2011 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 09/27/2007 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 02/08/2007 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 11/13/2003 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 09/22/2003 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/2002 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/20/1999 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1997 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/13/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/13/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/13/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/20/1989 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
CEPHALEXIN
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065248 | ANDA REPOSITORY |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062713 | BELCHER PHARMS |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065152 | CHARTWELL RX |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065229 | LUPIN |
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062702 | TEVA |
CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090836 | ALKEM LABS LTD |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065248 | ANDA REPOSITORY |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065253 | AUROBINDO PHARMA |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062713 | BELCHER PHARMS |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065152 | CHARTWELL RX |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065229 | LUPIN |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062702 | TEVA |