NDA 203629

FRESENIUS KABI USA

FDA Drug Application

Application #203629

Documents

• Letter: 2015-01-13
• Review: 2015-07-22
• Label: 2015-01-29
• Summary Review: 2015-07-22
• Letter: 2021-02-05
• Label: 2021-02-08

Application Sponsors

NDA 203629

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	5MG/10ML (0.5MG/ML)	0	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE
002	SOLUTION;INTRAVENOUS	10MG/10ML (1MG/ML)	0	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE
003	SOLUTION;INTRAVENOUS	3MG/3ML (1MG/ML)	0	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-01-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-02-04	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7

TE Codes

003

Prescription

AP

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 203629
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"10MG\/10ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"3MG\/3ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/08\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203629s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203629s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203629Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/203629Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/203629Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/31\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-07-31
        )

)