Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212080
Company: SENTISS
Company: SENTISS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | GEL;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 |
---|---|---|---|---|---|---|---|
02/10/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212080Orig1s000ltr.pdf |
LOTEPREDNOL ETABONATE
GEL;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% | GEL;OPHTHALMIC | Prescription | Yes | AB | 202872 | BAUSCH AND LOMB INC |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | GEL;OPHTHALMIC | Prescription | No | AB | 213956 | HIKMA |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | GEL;OPHTHALMIC | Prescription | No | AB | 212080 | SENTISS |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | GEL;OPHTHALMIC | Prescription | No | AB | 215384 | SUN PHARM |