Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065117
Company: SANDOZ INC
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 11/27/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065117.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2023 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/20/2010 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/29/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/31/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/26/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |