Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | AB | No | No |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/09/1976 | 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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-136 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-132 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2019 | SUPPL-131 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2017 | SUPPL-128 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2017 | SUPPL-127 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-121 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/02/2009 | SUPPL-117 | Labeling |
Label is not available on this site. |
||
| 07/17/2008 | SUPPL-116 | Labeling |
Label is not available on this site. |
||
| 05/31/2007 | SUPPL-113 | Labeling |
Label is not available on this site. |
||
| 07/30/2003 | SUPPL-110 | Labeling |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-106 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-105 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/14/2002 | SUPPL-102 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-101 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-100 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/13/2001 | SUPPL-99 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-97 | Labeling |
Label is not available on this site. |
||
| 07/24/2001 | SUPPL-96 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/2001 | SUPPL-95 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/04/2001 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-93 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/06/1999 | SUPPL-91 | Labeling |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1996 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1995 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1993 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 06/28/1993 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 09/02/1993 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1992 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 03/28/1989 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
AMOXICILLIN
CAPSULE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 065271 | AUROBINDO |
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 062058 | CHARTWELL |
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 065291 | HIKMA PHARMS |
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 207471 | MICRO LABS |
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 064076 | SANDOZ |
| AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 061926 | TEVA |
| AMOXIL | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | No | AB | 062216 | US ANTIBIOTICS |
CAPSULE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 065271 | AUROBINDO |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 062058 | CHARTWELL |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 065291 | HIKMA PHARMS |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 207471 | MICRO LABS |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 064076 | SANDOZ |
| AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 061926 | TEVA |
| AMOXIL | AMOXICILLIN | 500MG | CAPSULE;ORAL | Prescription | No | AB | 062216 | US ANTIBIOTICS |