Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012489
Company: AH ROBINS INC
Company: AH ROBINS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXNA | BENZTHIAZIDE | 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 |
|---|---|---|---|---|---|---|---|
| 10/14/1960 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 12/01/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/13/1983 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/11/1986 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/12/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/1981 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1977 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1976 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/02/1976 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/25/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |