Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205222
Company: LANNETT CO INC
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
05/25/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVOFLOXACIN
SOLUTION;ORAL; 250MG/10ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | Prescription | No | AA | 205222 | LANNETT CO INC |
LEVOFLOXACIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | Prescription | No | AA | 091678 | NOVITIUM PHARMA |