Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 10MG | 0 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1995-09-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-07-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-11-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-03-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-05-29 | |
LABELING; Labeling | SUPPL | 21 | AP | 2010-03-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2013-04-02 | UNKNOWN |
LABELING; Labeling | SUPPL | 33 | AP | 2013-04-11 | 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 | 32 | Null | 7 |
SUPPL | 33 | Null | 15 |
TE Codes
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 74421
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"CYCLOBENZAPRINE HYDROCHLORIDE","activeIngredients":"CYCLOBENZAPRINE HYDROCHLORIDE","strength":"10MG","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"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)