Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | SOLUTION;OPHTHALMIC | 1% | 1 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE |
| 002 | SOLUTION;OPHTHALMIC | 2% | 1 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE |
| 003 | SOLUTION;OPHTHALMIC | 4% | 1 | ISOPTO CARPINE | PILOCARPINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2010-06-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2013-02-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2014-01-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2014-02-12 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
TE Codes
| 001 | Prescription | AT |
| 002 | Prescription | AT |
| 003 | Prescription | AT |
CDER Filings
NOVARTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 200890
[companyName] => NOVARTIS
[docInserts] => ["",""]
[products] => [{"drugName":"ISOPTO CARPINE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ISOPTO CARPINE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"2%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ISOPTO CARPINE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"4%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/08\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200890s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200890s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/22\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200890s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200890s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200890_carpine_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200890s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"02\/12\/2014","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/27\/2014","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/07\/2013","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/08\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200890s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200890s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2014-02-12
)
)