Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER, METERED;INHALATION | 0.08MG/INH | 1 | PULMICORT FLEXHALER | BUDESONIDE |
| 002 | POWDER, METERED;INHALATION | 0.16MG/INH | 1 | PULMICORT FLEXHALER | BUDESONIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2006-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2007-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2008-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2008-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2010-07-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2015-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2016-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-09-06 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 7 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 15 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 21949
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"PULMICORT FLEXHALER","activeIngredients":"BUDESONIDE","strength":"0.08MG\/INH","dosageForm":"POWDER, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PULMICORT FLEXHALER","activeIngredients":"BUDESONIDE","strength":"0.16MG\/INH","dosageForm":"POWDER, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021949s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2010","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021949s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2008","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021949s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2008","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021949s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2007","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021949s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2007","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021949s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021949lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PULMICORT FLEXHALER","submission":"BUDESONIDE","actionType":"0.08MG\/INH","submissionClassification":"POWDER, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PULMICORT FLEXHALER","submission":"BUDESONIDE","actionType":"0.16MG\/INH","submissionClassification":"POWDER, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-09-06
)
)