Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203431
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 07/10/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203431Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/03/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/27/2020 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/27/2020 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC; 0.004%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAVATAN Z | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 021994 | SANDOZ |
| TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 203431 | APOTEX |
| TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 203767 | MICRO LABS |
| TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 205050 | MYLAN |