Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040353
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE | SPIRONOLACTONE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| SPIRONOLACTONE | SPIRONOLACTONE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| SPIRONOLACTONE | SPIRONOLACTONE | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40353ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/22/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2011 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/11/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/30/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/15/2006 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/15/2006 | SUPPL-7 |
Label is not available on this site. |
|||
| 11/02/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |