Documents
Application Sponsors
| NDA 021569 | LIEBEL-FLARSHEIM | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 405MG/50ML (9MG/ML) | 1 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE |
| 002 | INJECTABLE;INJECTION | 1012.5MG/125ML (9MG/ML) | 1 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2006-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2008-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2009-10-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2012-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2013-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-12-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 15 |
CDER Filings
LIEBEL-FLARSHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 21569
[companyName] => LIEBEL-FLARSHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"405MG\/50ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"1012.5MG\/125ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/29\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021569s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2012","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021569s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021569s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2008","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021569s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021569PI.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"405MG\/50ML (9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"1012.5MG\/125ML (9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-29
)
)