Application Sponsors
| ANDA 071611 | ACTAVIS LABS FL INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 10MG | 0 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 5MG | 0 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 7.5MG | 0 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1988-02-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1990-02-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1992-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1992-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1993-03-12 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1993-03-12 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1993-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1993-12-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1998-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2001-04-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2006-02-03 | |
| LABELING; Labeling | SUPPL | 39 | AP | 2006-02-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2006-02-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 2012-09-24 | |
| LABELING; Labeling | SUPPL | 69 | AP | 2013-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2013-07-30 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | 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 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 23 | 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 | 30 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 67 | Null | 15 |
| SUPPL | 69 | Null | 15 |
| SUPPL | 70 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 71611
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOBENZAPRINE HYDROCHLORIDE","submission":"CYCLOBENZAPRINE HYDROCHLORIDE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)