Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205055
Company: ALVOGEN
Company: ALVOGEN
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 |
---|---|---|---|---|---|---|---|
12/11/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205055Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/15/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2018 | SUPPL-1 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |