Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN | AMOXICILLIN | 250MG | TABLET, CHEWABLE;ORAL | Prescription | None | No | Yes |
AMOXICILLIN | AMOXICILLIN | 125MG | TABLET, CHEWABLE;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/22/1992 | 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-64 | Labeling-Package Insert |
Label is not available on this site. |
||
01/03/2024 | SUPPL-61 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/04/2019 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
05/18/2017 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
05/18/2017 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2015 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
02/02/2009 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
07/17/2008 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
05/31/2007 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
08/29/2003 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
12/09/2002 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/10/2002 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/14/2002 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/20/2002 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/20/2002 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/13/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
09/10/2001 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/10/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/10/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/27/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/23/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
05/15/2001 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/04/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/07/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/12/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/06/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
08/28/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/12/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
08/26/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/12/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/13/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |