Details for New Drug Application (NDA): 019863

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NDA 019863 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 019863

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/AMP Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019863

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono	GEREF	sermorelin acetate	INJECTABLE;INJECTION	019863-001	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Emd Serono	GEREF	sermorelin acetate	INJECTABLE;INJECTION	019863-001	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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