Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017575
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DTIC-DOME | DACARBAZINE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DTIC-DOME | DACARBAZINE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/27/1975 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 09/24/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1991 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/05/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/15/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1980 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1981 | SUPPL-3 | Efficacy |
Label is not available on this site. |
||
| 05/24/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |