Application Sponsors
| NDA 018397 | BAYER HEALTHCARE LLC | |
Marketing Status
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 8MG;120MG | 1 | CHLOR-TRIMETON | CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1981-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1981-05-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1982-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1984-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1984-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-07-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1997-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-11-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-04-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-01-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-10-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-11-09 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
CDER Filings
BAYER HEALTHCARE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 18397
[companyName] => BAYER HEALTHCARE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLOR-TRIMETON","activeIngredients":"CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE","strength":"8MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLOR-TRIMETON","submission":"CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE","actionType":"8MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)