Drugs@FDA: FDA-Approved Drugs
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALIUM | DIAZEPAM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/24/1966 | 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 |
|---|---|---|---|---|---|
| 09/04/1998 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1997 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1997 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-81 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf |
| 05/25/1993 | SUPPL-80 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-79 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf |
| 04/23/1987 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1986 | SUPPL-74 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1986 | SUPPL-72 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/15/1986 | SUPPL-71 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1985 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 05/31/1985 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1983 | SUPPL-63 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/29/1983 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1983 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 03/14/1983 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 03/14/1983 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 04/06/1983 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1982 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1982 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1982 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1982 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1982 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 11/19/1981 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/1981 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 11/13/1981 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 08/24/1981 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1981 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1981 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1980 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 11/02/1979 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 05/31/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/15/1980 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1978 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1977 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/23/1976 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/23/1976 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/13/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1975 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1974 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1974 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/1974 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/20/1974 | SUPPL-22 | Labeling |
Label is not available on this site. |