Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077467
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NATEGLINIDE | NATEGLINIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| NATEGLINIDE | NATEGLINIDE | 120MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2007 | ORIG-1 | Tentative Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077467s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077467s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2007 | ORIG-1 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077467s000lbl.pdf |