Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204227
Company: SANDOZ
Company: SANDOZ
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/23/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 | 202653 | LUPIN LTD |
GATIFLOXACIN | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 204227 | SANDOZ |
ZYMAXID | GATIFLOXACIN | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 022548 | ABBVIE |