BLA 021684

EMD SERONO

FDA Drug Application

Application #021684

Documents

• Letter: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Review: 2020-03-23
• Other: 2020-03-23

Application Sponsors

BLA 021684

EMD SERONO

Marketing Status

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

Application Products

001	INJECTABLE;SUBCUTANEOUS	300 IU/0.5ML	0	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA
002	INJECTABLE;SUBCUTANEOUS	450 IU/0.75ML	0	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA
003	INJECTABLE;SUBCUTANEOUS	900 IU/1.5ML	0	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA
004	INJECTABLE;SUBCUTANEOUS	150 IU/0.25ML	0	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-05-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	2007-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2007-12-06	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2013-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2013-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2013-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2013-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2013-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2013-10-16	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2017-11-06	N/A

Submissions Property Types

SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	15
SUPPL	38	Null	6

CDER Filings

EMD SERONO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21684
            [companyName] => EMD SERONO
            [docInserts] => ["",""]
            [products] => [{"drugName":"GONAL-F RFF REDI-JECT","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"300 IU\/0.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GONAL-F RFF REDI-JECT","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"450 IU\/0.75ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GONAL-F RFF REDI-JECT","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"900 IU\/1.5ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GONAL-F RFF REDI-JECT","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"150 IU\/0.25ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/16\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021684s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021684s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21684_gonal-f_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GONAL-F RFF REDI-JECT","submission":"FOLLITROPIN ALFA\/BETA","actionType":"300 IU\/0.5ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GONAL-F RFF REDI-JECT","submission":"FOLLITROPIN ALFA\/BETA","actionType":"450 IU\/0.75ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GONAL-F RFF REDI-JECT","submission":"FOLLITROPIN ALFA\/BETA","actionType":"900 IU\/1.5ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GONAL-F RFF REDI-JECT","submission":"FOLLITROPIN ALFA\/BETA","actionType":"150 IU\/0.25ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-10-16
        )

)