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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018123

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NDA 018123 describes FACTREL, which is a drug marketed by Hikma and is included in one NDA. Additional details are available on the FACTREL profile page.

The generic ingredient in FACTREL is gonadorelin hydrochloride. There are seven drug master file entries for this compound. Additional details are available on the gonadorelin hydrochloride profile page.

Summary for 018123

Tradename:	FACTREL
Applicant:	Hikma
Ingredient:	gonadorelin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.1MG BASE/VIAL
Approval Date:	Sep 30, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.2MG BASE/VIAL
Approval Date:	Sep 30, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.5MG BASE/VIAL
Approval Date:	Sep 30, 1982	TE:		RLD:	No

Expired US Patents for NDA 018123

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	⤷ Get Started Free	⤷ Get Started Free
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	⤷ Get Started Free	⤷ Get Started Free
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	⤷ Get Started Free	⤷ Get Started Free
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	⤷ Get Started Free	⤷ Get Started Free
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	⤷ Get Started Free	⤷ Get Started Free
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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