NDA 212849

SHANDONG LUYE PHARMACEUTICAL CO LTD

FDA Drug Application

Application #212849

Documents

• Letter: 2023-01-17
• Label: 2023-01-17

Application Sponsors

NDA 212849

SHANDONG LUYE PHARMACEUTICAL CO LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTION, SUSPENSION, EXTENDED RELEASE	12.5MG	0	RYKINDO	RISERIDONE
002	INJECTION, SUSPENSION, EXTENDED RELEASE	25MG	0	RYKINDO	RISERIDONE
003	INJECTION, SUSPENSION, EXTENDED RELEASE	37.5MG	0	RYKINDO	RISERIDONE
004	INJECTION, SUSPENSION, EXTENDED RELEASE	50MG	0	RYKINDO	RISERIDONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2023-01-13

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SHANDONG LUYE PHARMACEUTICAL CO LTD

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            [companyName] => SHANDONG LUYE PHARMACEUTICAL CO LTD
            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"01\/13\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/212849s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2023-01-13
        )

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