Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207606
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 0.05% | EMULSION;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 |
---|---|---|---|---|---|---|---|
01/12/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CYCLOSPORINE
EMULSION;OPHTHALMIC; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | No | AB | 207606 | APOTEX |
CYCLOSPORINE | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | No | AB | 209811 | DEVA HOLDING AS |
CYCLOSPORINE | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | No | AB | 205894 | MYLAN |
CYCLOSPORINE | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | No | AB | 211943 | SAPTALIS PHARMS |
RESTASIS | CYCLOSPORINE | 0.05% | EMULSION;OPHTHALMIC | Prescription | Yes | AB | 050790 | ABBVIE |