Documents
Application Sponsors
| NDA 022113 | GLAXOSMITHKLINE | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | TABLET;ORAL | 4MG;200MG;10MG | 1 | ADVIL ALLERGY AND CONGESTION RELIEF | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 4MG;200MG;10MG | 1 | ADVIL MULTI-SYMPTOM COLD & FLU | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2011-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-11-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 11 | Null | 7 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 22113
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"ADVIL ALLERGY AND CONGESTION RELIEF","activeIngredients":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE","strength":"4MG;200MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ADVIL MULTI-SYMPTOM COLD & FLU","activeIngredients":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE","strength":"4MG;200MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022113Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022113Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022113Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022113Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022113Orig1s001lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ADVIL ALLERGY AND CONGESTION RELIEF","submission":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE","actionType":"4MG;200MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ADVIL MULTI-SYMPTOM COLD & FLU","submission":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE","actionType":"4MG;200MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-09-06
)
)