Documents
Application Sponsors
| ANDA 065382 | SUN PHARM INDS LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 125MG/5ML | 0 | CLARITHROMYCIN | CLARITHROMYCIN |
| 002 | FOR SUSPENSION;ORAL | 250MG/5ML | 0 | CLARITHROMYCIN | CLARITHROMYCIN |
FDA Submissions
| ORIG | 1 | AP | 2007-08-30 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2008-09-09 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-07-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 24 |
| SUPPL | 3 | Null | 24 |
| SUPPL | 4 | Null | 15 |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 65382
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"125MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"250MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/30\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/065382s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CLARITHROMYCIN","submission":"CLARITHROMYCIN","actionType":"125MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLARITHROMYCIN","submission":"CLARITHROMYCIN","actionType":"250MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2007-08-30
)
)