Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 204227
Company: SANDOZ INC
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GATIFLOXACIN | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 07/11/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204227Orig1s000ltr.pdf |
GATIFLOXACIN
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GATIFLOXACIN | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 203189 | HI-TECH PHARMA CO |
| GATIFLOXACIN | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202653 | LUPIN LTD |
| GATIFLOXACIN | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 206446 | MYLAN PHARMS INC |
| GATIFLOXACIN | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 204227 | SANDOZ INC |
| ZYMAXID | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 022548 | ALLERGAN |
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