Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/100ML | 0 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2013-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-05-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2014-03-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2014-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2015-08-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2015-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2015-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2016-03-25 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2022-04-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 19 | Null | 15 |
TE Codes
CDER Filings
INFORLIFE
cder:Array
(
[0] => Array
(
[ApplNo] => 203231
[companyName] => INFORLIFE
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/02\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203231s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203231s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203231s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203231s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/02\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203231s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203231Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203231Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203231Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"02\/02\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203231s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203231Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"03\/25\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203231s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203231Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203231s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203231Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2015","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/31\/2015","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/10\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s005s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/10\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s005s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/10\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s005s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203231Orig1s005,s006,s007ltr.pdf\"}]","notes":">"},{"actionDate":"03\/11\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/02\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203231s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203231Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"02\/07\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-02-02
)
)