Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075105
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
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 |
---|---|---|---|---|---|---|---|
07/23/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75105ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/22/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/23/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide_prntlbl.pdf |