Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207609
Company: SENTISS
Company: SENTISS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/17/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207609Orig1s000ltr.pdf |
LOTEPREDNOL ETABONATE
SUSPENSION/DROPS;OPHTHALMIC; 0.5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOTEMAX | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020583 | BAUSCH AND LOMB |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 215719 | LUPIN LTD |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 207609 | SENTISS |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 212450 | SUN PHARM |