Drugs@FDA: FDA-Approved Drugs
Company: US ANTIBIOTICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXIL | AMOXICILLIN | 250MG | CAPSULE;ORAL | Prescription | AB | No | No |
| AMOXIL | AMOXICILLIN | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1979 | 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-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2017 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/12/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 03/06/2009 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 02/17/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/07/2004 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/2001 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/31/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/16/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/19/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
AMOXIL
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 |