Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;IRRIGATION, URETHRAL | 250MG/100ML | 0 | ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1979-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1979-09-25 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1979-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1980-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1980-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1981-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1981-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1981-09-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1981-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1982-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1985-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1985-05-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1985-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1986-01-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1990-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2003-05-15 | |
Submissions Property Types
| SUPPL | 1 | 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 | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
TE Codes
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 18161
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"ACETIC ACID 0.25% IN PLASTIC CONTAINER","activeIngredients":"ACETIC ACID, GLACIAL","strength":"250MG\/100ML","dosageForm":"SOLUTION;IRRIGATION, URETHRAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETIC ACID 0.25% IN PLASTIC CONTAINER","submission":"ACETIC ACID, GLACIAL","actionType":"250MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION, URETHRAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)