Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022505

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EGRIFTA (TESAMORELIN ACETATE)
EQ 1MG BASE/VIAL Marketing Status: Prescription

Active Ingredient: TESAMORELIN ACETATE
Proprietary Name: EGRIFTA
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: EQ 1MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022505
Product Number: 001
Approval Date: Nov 10, 2010
Applicant Holder Full Name: THERATECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EGRIFTA (TESAMORELIN ACETATE)
EQ 2MG BASE/VIAL Marketing Status: Discontinued

Active Ingredient: TESAMORELIN ACETATE
Proprietary Name: EGRIFTA
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: EQ 2MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022505
Product Number: 002
Approval Date: Nov 29, 2011
Applicant Holder Full Name: THERATECHNOLOGIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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