Application Sponsors
| ANDA 201356 | INVAGEN PHARMS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 12.5MG;EQ 10MG BASE | 0 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
| 002 | TABLET;ORAL | 12.5MG;EQ 20MG BASE | 0 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
| 003 | TABLET;ORAL | 25MG;EQ 20MG BASE | 0 | QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2011-04-20 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-11-24 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-05-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 201356
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"12.5MG;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"12.5MG;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE","strength":"25MG;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/20\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/24\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-06
)
)