Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INDAPAMIDE | INDAPAMIDE | 2.5MG | TABLET;ORAL | Prescription | AB | No | Yes |
| 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 |
|---|---|---|---|---|---|---|---|
| 07/27/1995 | 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 |
|---|---|---|---|---|---|
| 09/28/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2017 | SUPPL-27 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/28/2001 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/28/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/2000 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/23/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/28/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/29/1996 | 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 |