Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209051
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAFLUPROST | TAFLUPROST | 0.0015% | 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 |
---|---|---|---|---|---|---|---|
08/19/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209051Orig1s000ltr.pdf |
TAFLUPROST
SOLUTION/DROPS;OPHTHALMIC; 0.0015%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TAFLUPROST | TAFLUPROST | 0.0015% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 209051 | MICRO LABS |
TAFLUPROST | TAFLUPROST | 0.0015% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 209040 | SANDOZ |
ZIOPTAN | TAFLUPROST | 0.0015% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 202514 | THEA PHARMA |