Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215081
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIFITEGRAST | LIFITEGRAST | 5% | SOLUTION/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 |
---|---|---|---|---|---|---|---|
08/04/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215081Orig1s000ltr.pdf |
LIFITEGRAST
SOLUTION/DROPS;OPHTHALMIC; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIFITEGRAST | LIFITEGRAST | 5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 215063 | EUGIA PHARMA |
LIFITEGRAST | LIFITEGRAST | 5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AB | 215081 | MICRO LABS |
XIIDRA | LIFITEGRAST | 5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 208073 | BAUSCH AND LOMB INC |