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Details for New Drug Application (NDA): 020898

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NDA 020898 describes THYROGEN, which is a drug marketed by Genzyme and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the THYROGEN profile page.

The generic ingredient in THYROGEN is thyrotropin alfa. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thyrotropin alfa profile page.

Summary for NDA: 020898

Tradename:
THYROGEN
Applicant:
Genzyme
Ingredient:
thyrotropin alfa
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020898

Ingredient-typeThyrotropin

Suppliers and Packaging for NDA: 020898

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THYROGEN
thyrotropin alfa
INJECTABLE;INJECTION 020898 NDA Genzyme Corporation 58468-0030 58468-0030-2 2 VIAL in 1 KIT (58468-0030-2) > 1 mL in 1 VIAL
THYROGEN
thyrotropin alfa
INJECTABLE;INJECTION 020898 NDA Genzyme Corporation 58468-1849 58468-1849-4 1 KIT in 1 CARTON (58468-1849-4) * 1 mL in 1 VIAL * 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.1MG/VIAL
Approval Date:Nov 30, 1998TE:RLD:Yes
Patent:5,840,566Patent Expiration:Nov 24, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020898

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
THYROGEN
thyrotropin alfa
INJECTABLE;INJECTION020898-001Nov 30, 19985,240,832► subscribe
Genzyme
THYROGEN
thyrotropin alfa
INJECTABLE;INJECTION020898-001Nov 30, 19985,840,566► subscribe
Genzyme
THYROGEN
thyrotropin alfa
INJECTABLE;INJECTION020898-001Nov 30, 19986,365,127► subscribe
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