Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012164
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NATURETIN-10 | BENDROFLUMETHIAZIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| NATURETIN-2.5 | BENDROFLUMETHIAZIDE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| NATURETIN-5 | BENDROFLUMETHIAZIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/07/1959 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/02/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1996 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1982 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 06/04/1982 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1981 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/16/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/04/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/16/1977 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/16/1977 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1976 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |