NDA 020443

EMD SERONO INC

FDA Drug Application

Application #020443

Application Sponsors

NDA 020443

EMD SERONO INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	GEREF	SERMORELIN ACETATE
002	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	GEREF	SERMORELIN ACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

1997-09-26

STANDARD

Submissions Property Types

ORIG

1

Orphan

5

CDER Filings

EMD SERONO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20443
            [companyName] => EMD SERONO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEREF","activeIngredients":"SERMORELIN ACETATE","strength":"EQ 0.5MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GEREF","activeIngredients":"SERMORELIN ACETATE","strength":"EQ 1MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GEREF","submission":"SERMORELIN ACETATE","actionType":"EQ 0.5MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GEREF","submission":"SERMORELIN ACETATE","actionType":"EQ 1MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)