Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210458
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | 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 |
---|---|---|---|---|---|---|---|
12/20/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC; 0.004%
TE Code = AT1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 210458 | ALEMBIC |
TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 091340 | CHARTWELL RX |