Details for New Drug Application (NDA): 019836

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NDA 019836 describes SUPPRELIN, which is a drug marketed by Shire and Endo Operations and is included in two NDAs. There is one patent protecting this drug. Additional details are available on the SUPPRELIN profile page.

The generic ingredient in SUPPRELIN is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.

Summary for 019836

Tradename:	SUPPRELIN
Applicant:	Shire
Ingredient:	histrelin acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.2MG BASE/ML
Approval Date:	Dec 24, 1991	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.5MG BASE/ML
Approval Date:	Dec 24, 1991	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Dec 24, 1991	TE:		RLD:	No

Expired US Patents for NDA 019836

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991	⤷ Sign Up	⤷ Sign Up
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991	⤷ Sign Up	⤷ Sign Up
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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