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Last Updated: April 17, 2024

Details for New Drug Application (NDA): 019886

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NDA 019886 describes SYNAREL, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the SYNAREL profile page.

The generic ingredient in SYNAREL is nafarelin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nafarelin acetate profile page.

Summary for 019886

Tradename:	SYNAREL
Applicant:	Pfizer
Ingredient:	nafarelin acetate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019886

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 019886

Fertility Agents, Female

Suppliers and Packaging for NDA: 019886

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SYNAREL	nafarelin acetate	SPRAY, METERED;NASAL	019886	NDA	Pfizer Laboratories Div Pfizer Inc	0025-0166	0025-0166-08	1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	EQ 0.2MG BASE/SPRAY
Approval Date:	Feb 13, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019886

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SYNAREL	nafarelin acetate	SPRAY, METERED;NASAL	019886-001	Feb 13, 1990	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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