Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021318

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FORTEO (TERIPARATIDE RECOMBINANT HUMAN)
0.6MG/2.4ML (0.25MG/ML) Marketing Status: Prescription

Active Ingredient: TERIPARATIDE RECOMBINANT HUMAN
Proprietary Name: FORTEO
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 0.6MG/2.4ML (0.25MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021318
Product Number: 002
Approval Date: Jun 25, 2008
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

FORTEO (TERIPARATIDE RECOMBINANT HUMAN)
0.75MG/3ML (0.25MG/ML) Marketing Status: Discontinued

Active Ingredient: TERIPARATIDE RECOMBINANT HUMAN
Proprietary Name: FORTEO
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 0.75MG/3ML (0.25MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021318
Product Number: 001
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

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