NDA 021703

BAXTER HLTHCARE CORP

FDA Drug Application

Application #021703

Documents

• Letter: 2012-04-16
• Letter: 2016-07-22
• Label: 2006-10-26
• Label: 2009-04-28
• Label: 2012-04-17
• Letter: 2006-10-27
• Letter: 2008-10-22
• Letter: 2013-06-12
• Letter: 2015-12-17
• Label: 2008-11-07
• Label: 2015-12-17
• Label: 2016-07-21
• Review: 2008-04-22
• Label: 2017-07-03
• Letter: 2017-07-05
• Label: 2018-12-06
• Letter: 2018-11-06

Application Sponsors

NDA 021703

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Discontinued: 005
• Prescription: 006
• Discontinued: 007
• Discontinued: 008
• Discontinued: 009
• Discontinued: 010
• Prescription: 011
• Discontinued: 012
• Discontinued: 013
• Prescription: 014
• Prescription: 015

Application Products

001	INJECTABLE;INJECTION	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
004	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
005	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	0	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
006	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
007	INJECTABLE;INJECTION	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	0	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
008	INJECTABLE;INJECTION	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	0	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
009	INJECTABLE;INJECTION	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	0	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
010	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	1	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
011	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	1	PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
012	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	0	PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
013	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	1	PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
014	INJECTABLE;INJECTION	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
015	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	1	PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2008-10-10	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2009-04-20	N/A
LABELING; Labeling	SUPPL	8	AP	2012-04-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-02-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-12-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-07-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2017-06-30	STANDARD
LABELING; Labeling	SUPPL	20	AP	2018-11-01	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	8	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	6
SUPPL	20	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21703
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRISMASOL B22GK 2\/0 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.157GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRISMASOL B22GK 2\/2.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.157GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRISMASOL B22GK 4\/0 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL B22GK 4\/2.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRISMASOL BGK 0\/2.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL BGK 2\/0 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;0.157GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL BGK 2\/3.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"5.15GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;0.157GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL BGK 4\/0 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRISMASOL BGK 4\/0\/1.2 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.44GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL BGK 4\/2.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL BGK 4\/3.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"5.15GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRISMASOL BK 0\/0 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRISMASOL BK 0\/0\/1.2 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"N\/A\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;2.44GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PRISMASOL BK 0\/3.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"5.15GM\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRISMASOL BK 4\/2.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","strength":"3.68GM\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/01\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"11\/01\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/30\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021703s018,207026s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021703s017,207026s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021703s016-207026s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2012","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021703s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2009","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021703s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2009","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021703s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2008","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021703s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2008","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021703s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021703lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PRISMASOL B22GK 2\/0 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.157GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL B22GK 2\/2.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.157GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRISMASOL B22GK 4\/0 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL B22GK 4\/2.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;2.21GM\/1000ML;7.07GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BGK 0\/2.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BGK 2\/0 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;0.157GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BGK 2\/3.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"5.15GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;0.157GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BGK 4\/0 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRISMASOL BGK 4\/0\/1.2 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.44GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BGK 4\/2.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"3.68GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BGK 4\/3.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"5.15GM\/1000ML;20GM\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRISMASOL BK 0\/0 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRISMASOL BK 0\/0\/1.2 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"N\/A\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;2.44GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BK 0\/3.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"5.15GM\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;2.03GM\/1000ML;N\/A\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRISMASOL BK 4\/2.5 IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE","actionType":"3.68GM\/1000ML;N\/A\/1000ML;5.4GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;3.09GM\/1000ML;6.46GM\/1000ML (5000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2018-11-01
        )

)