Documents
Application Sponsors
| ANDA 202144 | ACTAVIS LABS FL INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 8MG | 0 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 12MG | 0 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 16MG | 0 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | 32MG | 0 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2014-05-12 | |
| REMS; REMS | SUPPL | 5 | AP | 2014-08-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2016-06-30 | |
| REMS; REMS | SUPPL | 7 | AP | 2015-06-26 | |
| REMS; REMS | SUPPL | 8 | AP | 2016-04-20 | |
| REMS; REMS | SUPPL | 10 | AP | 2016-09-30 | |
| REMS; REMS | SUPPL | 13 | AP | 2017-05-26 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2017-11-07 | STANDARD |
| REMS; REMS | SUPPL | 15 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 18 | Null | 15 |
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202144
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"12MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"16MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"32MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/30\/2016","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202144s006lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/12\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202144Orig1s000lbl&MG.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/12\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202144Orig1s000lbl&MG.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202144Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-18","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/04\/2021","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-15","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/07\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-13","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-10","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2016","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202144s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202144Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"08\/19\/2014","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-03-04
)
)