Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021994
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAVATAN Z | TRAVOPROST | 0.004% | 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 |
---|---|---|---|---|---|---|---|
09/21/2006 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021994lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021994s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021994s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/02/2020 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021994s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021994Orig1s013ltr.pdf | |
09/22/2017 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021994Orig1s012ltr.pdf | |
03/11/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/07/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021994s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021994s006ltr.pdf | |
08/31/2010 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021994s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021994s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/02/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021994s013lbl.pdf | |
09/22/2017 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf | |
09/22/2017 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021994s012lbl.pdf | |
09/07/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021994s006lbl.pdf | |
08/31/2010 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021994s001lbl.pdf | |
09/21/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021994lbl.pdf |
TRAVATAN Z
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 | 218159 | GLAND PHARMA LTD |
TRAVOPROST | TRAVOPROST | 0.004% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 207040 | LUPIN LTD |
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 |