Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084767
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIMENHYDRINATE | DIMENHYDRINATE | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/13/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/27/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |