Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 50MG | 1 | PRECOSE | ACARBOSE |
| 002 | TABLET;ORAL | 100MG | 1 | PRECOSE | ACARBOSE |
| 004 | TABLET;ORAL | 25MG | 1 | PRECOSE | ACARBOSE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1995-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1996-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 1998-09-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1998-09-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 1998-02-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 1999-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2002-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2005-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2008-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2011-03-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 25 | AP | 2012-02-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2014-11-11 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2015-03-09 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 15 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20482
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)