Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062226
Company: US ANTIBIOTICS
Company: US ANTIBIOTICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXIL | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
| AMOXIL | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
| AMOXIL | AMOXICILLIN | 50MG/ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
| LAROTID | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
| LAROTID | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 11/27/1979 | 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-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2017 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/12/2009 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/06/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/17/2009 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 10/07/2004 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-29 | 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-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/22/1995 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/19/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/11/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
AMOXIL
FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 204030 | AUROBINDO PHARMA LTD |
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065322 | HIKMA |
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065387 | SANDOZ |
| AMOXIL | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
| LAROTID | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 204030 | AUROBINDO PHARMA LTD |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065322 | HIKMA |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065387 | SANDOZ |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 061931 | TEVA |
| AMOXIL | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
| LAROTID | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
FOR SUSPENSION;ORAL; 50MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN PEDIATRIC | AMOXICILLIN | 50MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 061931 | TEVA |
| AMOXIL | AMOXICILLIN | 50MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
LAROTID
FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 204030 | AUROBINDO PHARMA LTD |
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065322 | HIKMA |
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065387 | SANDOZ |
| AMOXIL | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
| LAROTID | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 204030 | AUROBINDO PHARMA LTD |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065322 | HIKMA |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065387 | SANDOZ |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 061931 | TEVA |
| AMOXIL | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |
| LAROTID | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062226 | US ANTIBIOTICS |