Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | INJECTABLE;INJECTION | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | OXYTOCIN |
002 | INJECTABLE;INJECTION | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | OXYTOCIN |
003 | INJECTABLE;INJECTION | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN |
004 | INJECTABLE;INJECTION | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | OXYTOCIN |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1985-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1986-11-13 | |
CDER Filings
ABBOTT
cder:Array
(
[0] => Array
(
[ApplNo] => 19185
[companyName] => ABBOTT
[docInserts] => ["",""]
[products] => [{"drugName":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYTOCIN 20 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYTOCIN 5 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OXYTOCIN 20 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OXYTOCIN 5 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)