Documents
Application Sponsors
ANDA 207042 | EUROHLTH INTL SARL | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
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 |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-12-28 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2022-06-08 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
EUROHLTH INTL SARL
cder:Array
(
[0] => Array
(
[ApplNo] => 207042
[companyName] => EUROHLTH INTL SARL
[docInserts] => ["",""]
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[labels] => [{"actionDate":"12\/28\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207042lbl.pdf\"}]","notes":""}]
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[supplements] =>
[actionDate] => 2015-12-28
)
)