Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050460
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXIL | AMOXICILLIN | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |
AMOXIL | AMOXICILLIN | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |
AMOXIL | AMOXICILLIN | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |
LAROTID | AMOXICILLIN | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/18/1974 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |