Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074461
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDAPAMIDE | INDAPAMIDE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
INDAPAMIDE | INDAPAMIDE | 1.25MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/27/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/25/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/25/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
06/14/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/20/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/26/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/26/1997 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
INDAPAMIDE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INDAPAMIDE | INDAPAMIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 074722 | ACTAVIS ELIZABETH |
INDAPAMIDE | INDAPAMIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 074299 | ANI PHARMS |
INDAPAMIDE | INDAPAMIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 074461 | RISING |
TABLET;ORAL; 1.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INDAPAMIDE | INDAPAMIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB | 074722 | ACTAVIS ELIZABETH |
INDAPAMIDE | INDAPAMIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB | 074299 | ANI PHARMS |
INDAPAMIDE | INDAPAMIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB | 074461 | RISING |