Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084316
Company: WYETH AYERST
Company: WYETH AYERST
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 |
---|---|---|---|---|---|---|---|
08/18/1975 | 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 |
---|---|---|---|---|---|
07/30/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/21/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
03/26/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
09/09/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |