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Details for New Drug Application (NDA): 021318

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NDA 021318 describes FORTEO, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTEO profile page.

The generic ingredient in FORTEO is teriparatide recombinant human. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the teriparatide recombinant human profile page.

Summary for NDA: 021318

Tradename:
FORTEO
Applicant:
Lilly
Ingredient:
teriparatide recombinant human
Patents:7
Formulation / Manufacturing:see details

Pharmacology for NDA: 021318

Ingredient-typeParathyroid Hormone

Suppliers and Packaging for NDA: 021318

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTEO
teriparatide recombinant human
INJECTABLE;SUBCUTANEOUS 021318 NDA Eli Lilly and Company 0002-8400 0002-8400-01 1 SYRINGE in 1 CARTON (0002-8400-01) > 2.4 mL in 1 SYRINGE
FORTEO
teriparatide recombinant human
INJECTABLE;SUBCUTANEOUS 021318 NDA Eli Lilly and Company 0002-8400 0002-8400-99 1 SYRINGE in 1 CARTON (0002-8400-99) > 2.4 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength0.75MG/3ML (0.25MG/ML)
Approval Date:Nov 26, 2002TE:RLD:No
Patent:7,144,861Patent Expiration:Dec 8, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:7,517,334Patent Expiration:Mar 25, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,550,434Patent Expiration:Dec 8, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TREATING OSTEOPOROSIS


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