Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087999
Company: PUREPAC PHARM
Company: PUREPAC PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/06/1985 | 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 |
|---|---|---|---|---|---|
| 10/02/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/15/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |