Documents
Application Sponsors
| NDA 019085 | BOEHRINGER INGELHEIM | |
Marketing Status
Application Products
| 001 | AEROSOL, METERED;INHALATION | 0.018MG/INH | 0 | ATROVENT | IPRATROPIUM BROMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1986-12-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-04-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-04-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 1989-03-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-03-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-01-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 1994-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-06-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1997-01-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-05-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 1994-06-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-01-31 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 1996-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1996-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-11-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2009-03-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-11-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-08-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-09-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-08-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 21 | AP | 2009-03-13 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 19085
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"ATROVENT","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.018MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ATROVENT","submission":"IPRATROPIUM BROMIDE","actionType":"0.018MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)