Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | Yes |
| AMOXICILLIN PEDIATRIC | AMOXICILLIN | 50MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 12/01/1982 | 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-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-56 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2019 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2017 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2017 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/02/2009 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/17/2008 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/31/2007 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 04/19/2004 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/2002 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/14/2002 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/13/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/15/2001 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/14/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/22/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/14/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
AMOXICILLIN
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 |
AMOXICILLIN PEDIATRIC
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 |