Details for New Drug Application (NDA): 020378

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NDA 020378 describes GONAL-F, which is a drug marketed by Emd Serono and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the GONAL-F profile page.

The generic ingredient in GONAL-F is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.

Summary for 020378

Tradename:	GONAL-F
Applicant:	Emd Serono
Ingredient:	follitropin alfa/beta
Patents:	1
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 020378

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378	NDA	EMD Serono, Inc.	44087-9030	44087-9030-1	1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE
GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378	NDA	EMD Serono, Inc.	44087-9070	44087-9070-1	1 KIT in 1 CARTON (44087-9070-1) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	75 IU/VIAL
Approval Date:	Sep 29, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	150 IU/VIAL
Approval Date:	Sep 29, 1997	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	37.5 IU/VIAL
Approval Date:	May 25, 2000	TE:		RLD:	No

Expired US Patents for NDA 020378

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono	GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378-003	May 25, 2000	➤ Sign Up	➤ Sign Up
Emd Serono	GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378-001	Sep 29, 1997	➤ Sign Up	➤ Sign Up
Emd Serono	GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378-002	Sep 29, 1997	➤ Sign Up	➤ Sign Up
Emd Serono	GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378-005	Mar 26, 2004	➤ Sign Up	➤ Sign Up
Emd Serono	GONAL-F	follitropin alfa/beta	INJECTABLE;SUBCUTANEOUS	020378-005	Mar 26, 2004	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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