Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077700
Company: RISING PHARMA
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/20/2010 | ORIG-1 | Approval |
Label is not available on this site. |
LEVOFLOXACIN
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 077700 | RISING PHARMA |