Documents
Application Sponsors
| NDA 018761 | BOEHRINGER INGELHEIM | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | SOLUTION;INHALATION | 0.6% | 0 | ALUPENT | METAPROTERENOL SULFATE |
| 002 | SOLUTION;INHALATION | 0.4% | 0 | ALUPENT | METAPROTERENOL SULFATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1983-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1985-03-02 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1985-10-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1986-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1986-07-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1990-03-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1990-08-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-10-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2002-01-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
CDER Filings
BOEHRINGER INGELHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 18761
[companyName] => BOEHRINGER INGELHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"0.6%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"0.4%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"0.6%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"0.4%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)