Application 021684

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	INJECTABLE;SUBCUTANEOUS	300 IU/0.5ML	No	No
002	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	INJECTABLE;SUBCUTANEOUS	450 IU/0.75ML	No	No
003	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	INJECTABLE;SUBCUTANEOUS	900 IU/1.5ML	No	No
004	GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	INJECTABLE;SUBCUTANEOUS	150 IU/0.25ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	BLA	Current
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	BLA	Current
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	BLA	Current
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	BLA	Current
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	BLA	Current
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	BLA	Current
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current
44087-1118	Gonal-f RFF Redi-ject	FOLLITROPIN	EMD Serono, Inc.	NDA	Current