Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090227
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 1GM;EQ 62.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/21/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090227s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2024 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |