Documents
Application Sponsors
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 002 | POWDER, METERED;INHALATION | 0.16MG/INH | 0 | PULMICORT | BUDESONIDE |
| 003 | POWDER, METERED;INHALATION | 0.32MG/INH | 0 | PULMICORT | BUDESONIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-06-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1998-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-04-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-12-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-10-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2001-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2003-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2003-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2003-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2007-08-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 20441
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"PULMICORT","activeIngredients":"BUDESONIDE","strength":"0.16MG\/INH","dosageForm":"POWDER, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PULMICORT","activeIngredients":"BUDESONIDE","strength":"0.32MG\/INH","dosageForm":"POWDER, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/20\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020441s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2003","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20441slr017_pulmicort_lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2003","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20441slr016_pulmicort_lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2003","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/1998","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20441s2.lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PULMICORT","submission":"BUDESONIDE","actionType":"0.16MG\/INH","submissionClassification":"POWDER, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PULMICORT","submission":"BUDESONIDE","actionType":"0.32MG\/INH","submissionClassification":"POWDER, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2007-08-20
)
)