Application Sponsors
| NDA 018685 | SANOFI AVENTIS US | |
Marketing Status
| Over-the-counter | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, CHEWABLE;ORAL | 80MG;20MG | 1 | GAVISCON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE |
| 002 | TABLET, CHEWABLE;ORAL | 160MG;40MG | 1 | GAVISCON | ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1983-12-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-10-01 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1995-01-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-04-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-09-13 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | 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 | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 18685
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"GAVISCON","activeIngredients":"ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE","strength":"80MG;20MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"GAVISCON","activeIngredients":"ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE","strength":"160MG;40MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GAVISCON","submission":"ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE","actionType":"80MG;20MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"GAVISCON","submission":"ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE","actionType":"160MG;40MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)