Documents
Application Sponsors
| ANDA 074752 | ACTAVIS LABS FL INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 180MG | 0 | CARTIA XT | DILTIAZEM HYDROCHLORIDE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | 0 | CARTIA XT | DILTIAZEM HYDROCHLORIDE |
| 003 | CAPSULE, EXTENDED RELEASE;ORAL | 240MG | 0 | CARTIA XT | DILTIAZEM HYDROCHLORIDE |
| 004 | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | 0 | CARTIA XT | DILTIAZEM HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1998-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-06-08 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1999-04-02 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1999-06-08 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1999-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-07-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-08-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-01-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-01-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-02-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-12-24 | |
| S; Supplement | SUPPL | 18 | AP | 2003-11-18 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2006-12-04 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2007-05-11 | |
| LABELING; Labeling | SUPPL | 38 | AP | 2011-10-28 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 38 | Null | 15 |
TE Codes
| 001 | Prescription | AB3 |
| 002 | Prescription | AB3 |
| 003 | Prescription | AB3 |
| 004 | Prescription | AB3 |
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 74752
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"CARTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"180MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"240MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARTIA XT","activeIngredients":"DILTIAZEM HYDROCHLORIDE","strength":"300MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/09\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/74752lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CARTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"180MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"120MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"240MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARTIA XT","submission":"DILTIAZEM HYDROCHLORIDE","actionType":"300MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1998-07-09
)
)