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Generated: January 15, 2019

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Details for New Drug Application (NDA): 017692

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NDA 017692 describes PREGNYL, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PREGNYL profile page.

The generic ingredient in PREGNYL is gonadotropin, chorionic. Three suppliers are listed for this compound. Additional details are available on the gonadotropin, chorionic profile page.
Summary for 017692
Applicant:Organon Usa Inc
Ingredient:gonadotropin, chorionic
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGNYL gonadotropin, chorionic INJECTABLE;INJECTION 017692 NDA Organon USA Inc. 0052-0315 0052-0315-10 1 KIT in 1 CARTON (0052-0315-10) * 10 mL in 1 VIAL * 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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