Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087511
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE | 25MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/25/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |