Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075201
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDAPAMIDE | INDAPAMIDE | 1.25MG | TABLET;ORAL | Discontinued | None | No | No |
| INDAPAMIDE | INDAPAMIDE | 2.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/04/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75201ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/16/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |