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Details for New Drug Application (NDA): 019886

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NDA 019886 describes SYNAREL, which is a drug marketed by Gd Searle Llc 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 NDA: 019886

Tradename:
SYNAREL
Applicant:
Gd Searle Llc
Ingredient:
nafarelin acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 G.D. Searle LLC Division of Pfizer Inc 0025-0166 0025-0166-08 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) > 8 mL in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.2MG BASE/SPRAY
Approval Date:Feb 13, 1990TE:RLD:Yes

Expired Orange Book Patents for NDA: 019886

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
SYNAREL
nafarelin acetate
SPRAY, METERED;NASAL019886-001Feb 13, 19904,234,571► subscribe
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