Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202793
Company: NOVEL LABS INC
Company: NOVEL LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | None (Tentative Approval) | None | No | No |
AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
08/26/2016 | ORIG-1 | Tentative Approval |
Label is not available on this site. |