Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065100
Company: RANBAXY LABS LTD
Company: RANBAXY LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PANIXINE DISPERDOSE | CEPHALEXIN | EQ 250MG BASE | TABLET, FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| PANIXINE DISPERDOSE | CEPHALEXIN | EQ 125MG BASE | TABLET, FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 09/11/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065100.pdf |