Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073334
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | EQ 5MG ANHYDROUS;50MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/1991 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |