NDA 213536

SINTETICA, SA

FDA Drug Application

Application #213536

Documents

• Letter: 2021-06-15
• Label: 2021-06-15
• Review: 2021-11-16

Application Sponsors

NDA 213536

SINTETICA, SA

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	4.7MG/ML	0	REZIPRES	EPHEDRINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	9.4MG/ML	0	REZIPRES	EPHEDRINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	47MG/ML	0	REZIPRES	EPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-06-14

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SINTETICA, SA

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    [0] => Array
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            [companyName] => SINTETICA, SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"REZIPRES","activeIngredients":"EPHEDRINE HYDROCHLORIDE","strength":"4.7MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REZIPRES","activeIngredients":"EPHEDRINE HYDROCHLORIDE","strength":"9.4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REZIPRES","activeIngredients":"EPHEDRINE HYDROCHLORIDE","strength":"47MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213536s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2021-06-14
        )

)