Application Sponsors
ANDA 086179 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 350MG | 0 | CARISOPRODOL | CARISOPRODOL |
FDA Submissions
| ORIG | 1 | AP | 1979-06-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1986-09-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-09-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1984-10-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1987-08-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1987-04-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1987-08-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1987-08-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-08-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-08-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1988-08-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1988-08-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1994-02-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1994-02-02 | |
LABELING; Labeling | SUPPL | 30 | AP | 1992-05-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1996-06-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-06-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1997-07-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1997-07-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1997-07-07 | |
Submissions Property Types
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 33 | Null | 0 |
SUPPL | 34 | Null | 0 |
SUPPL | 35 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 86179
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CARISOPRODOL","submission":"CARISOPRODOL","actionType":"350MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)