Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | EMULSION;OPHTHALMIC | 0.05% | 1 | RESTASIS | CYCLOSPORINE |
| 002 | EMULSION;OPHTHALMIC | 0.05% | 1 | RESTASIS MULTIDOSE | CYCLOSPORINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-12-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2003-09-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2003-10-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2003-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2007-12-27 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2013-01-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2013-05-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2014-01-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2013-12-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2016-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2016-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2017-07-18 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 7 |
TE Codes
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 50790
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"RESTASIS","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"RESTASIS MULTIDOSE","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/18\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050790s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2016","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050790s024s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2016","submission":"SUPPL-24","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050790s024s025lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/31\/2013","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050790s021lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/03\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050790s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2003","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50790slr001_restasis_lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/050790lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RESTASIS","submission":"CYCLOSPORINE","actionType":"0.05%","submissionClassification":"EMULSION;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RESTASIS MULTIDOSE","submission":"CYCLOSPORINE","actionType":"0.05%","submissionClassification":"EMULSION;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-07-18
)
)