NDA 211488

FORSEE PHARMACEUTICALS CO., LTD.

FDA Drug Application

Application #211488

Documents

• Letter: 2021-05-26
• Label: 2021-06-02
• Review: 2021-10-25

Application Sponsors

NDA 211488

FORSEE PHARMACEUTICALS CO., LTD.

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;SUBCUTANEOUS

EQ 42 MG BASE

2

CAMCEVI KIT

LEUPROLIDE MESYLATE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2021-05-25

STANDARD

Submissions Property Types

ORIG

1

Null

40

TE Codes

001

Prescription

TBD

CDER Filings

FORSEE PHARMACEUTICALS CO., LTD.

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(
    [0] => Array
        (
            [ApplNo] => 211488
            [companyName] => FORSEE PHARMACEUTICALS CO., LTD.
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAMCEVI KIT","activeIngredients":"LEUPROLIDE MESYLATE","strength":"EQ 42 MG BASE","dosageForm":"EMULSION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/25\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211488s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211488s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211488Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-25
        )

)