Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209706
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALCAFTADINE | ALCAFTADINE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | None | 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 |
|---|---|---|---|---|---|---|---|
| 03/01/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ALCAFTADINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION/DROPS;OPHTHALMIC; 0.25%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALCAFTADINE | ALCAFTADINE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209706 | GLAND PHARMA LTD |
| LASTACAFT | ALCAFTADINE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 022134 | ABBVIE |