Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065161
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG;EQ 28.5MG BASE | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG;EQ 57MG BASE | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 12/03/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065161_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/28/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/26/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/08/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |