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Details for New Drug Application (NDA): 017067

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NDA 017067 describes CHORIONIC GONADOTROPIN, which is a drug marketed by Ferring, Bel Mar, and Fresenius Kabi Usa, and is included in three NDAs. It is available from two suppliers. Additional details are available on the CHORIONIC GONADOTROPIN profile page.

The generic ingredient in CHORIONIC GONADOTROPIN is gonadotropin, chorionic. Four suppliers are listed for this compound. Additional details are available on the gonadotropin, chorionic profile page.

Summary for NDA: 017067

Tradename:
CHORIONIC GONADOTROPIN
Applicant:
Fresenius Kabi Usa
Ingredient:
gonadotropin, chorionic
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 017067

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHORIONIC GONADOTROPIN
gonadotropin, chorionic
INJECTABLE;INJECTION 017067 NDA Fresenius Kabi USA, LLC 63323-025 63323-025-10 1 KIT in 1 PACKAGE (63323-025-10) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE
CHORIONIC GONADOTROPIN
gonadotropin, chorionic
INJECTABLE;INJECTION 017067 NDA Fresenius Kabi USA, LLC 63323-030 63323-030-11 1 KIT in 1 CARTON (63323-030-11) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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