Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202514
Company: THEA PHARMA
Company: THEA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZIOPTAN | TAFLUPROST | 0.0015% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/10/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202514s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202514s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202514s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/04/2015 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf | |
09/04/2015 | SUPPL-3 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202514Orig1s003,s004ltr.pdf | |
08/28/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/22/2013 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202514Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/04/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf | |
09/04/2015 | SUPPL-3 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202514s003s004lbl.pdf |
02/22/2013 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202514s001lbl.pdf | |
02/10/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202514s000lbl.pdf |
ZIOPTAN
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 |