Details for New Drug Application (NDA): 020443

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NDA 020443 describes GEREF, which is a drug marketed by Emd Serono and Emd Serono Inc and is included in two NDAs. Additional details are available on the GEREF profile page.

The generic ingredient in GEREF is sermorelin acetate. There is one drug master file entry for this compound. Additional details are available on the sermorelin acetate profile page.

Summary for 020443

Tradename:	GEREF
Applicant:	Emd Serono Inc
Ingredient:	sermorelin acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.5MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 26, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 26, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020443

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997	4,517,181	⤷ Get Started Free
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997	4,703,035	⤷ Get Started Free
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997	4,517,181	⤷ Get Started Free
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997	4,703,035	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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