Application Sponsors
| ANDA 201001 | DR REDDYS LABS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG | 0 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2011-05-31 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2013-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-11-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201001
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/31\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/17\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/17\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/07\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-11-17
)
)