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Last Updated: May 25, 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
Ingredient:nafarelin acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019886
Medical Subject Heading (MeSH) Categories for 019886
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:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.2MG BASE/SPRAY
Approval Date:Feb 13, 1990TE:RLD:Yes

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