Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062223
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
08/27/1979 | 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 |
---|---|---|---|---|---|
12/28/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/08/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |