Application Sponsors
| ANDA 090149 | DR REDDYS LABS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 5MG BASE;40MG | 0 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 10MG BASE;40MG | 0 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-07-05 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2011-12-12 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-09-27 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2016-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-11-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
DR REDDYS LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90149
[companyName] => DR REDDYS LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 5MG BASE;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","activeIngredients":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","strength":"EQ 10MG BASE;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 5MG BASE;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE","submission":"AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE","actionType":"EQ 10MG BASE;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)