Documents
Application Sponsors
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
| Over-the-counter | 003 |
| Over-the-counter | 004 |
Application Products
| 001 | CAPSULE;ORAL | 5MG | 1 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | 10MG | 1 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE |
| 003 | CAPSULE;ORAL | 5MG | 1 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE |
| 004 | CAPSULE;ORAL | 10MG | 1 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2009-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2010-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-02-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2019-12-13 | N/A |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-12-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 17 | Null | 6 |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22429
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES RELIEF","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES RELIEF","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022429Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022429Orig1s009lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CETIRIZINE HYDROCHLORIDE HIVES RELIEF","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CETIRIZINE HYDROCHLORIDE HIVES RELIEF","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-12-13
)
)