Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200677

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SIGNIFOR (PASIREOTIDE DIASPARTATE)
EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: PASIREOTIDE DIASPARTATE
Proprietary Name: SIGNIFOR
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200677
Product Number: 001
Approval Date: Dec 14, 2012
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SIGNIFOR (PASIREOTIDE DIASPARTATE)
EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: PASIREOTIDE DIASPARTATE
Proprietary Name: SIGNIFOR
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200677
Product Number: 002
Approval Date: Dec 14, 2012
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SIGNIFOR (PASIREOTIDE DIASPARTATE)
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: PASIREOTIDE DIASPARTATE
Proprietary Name: SIGNIFOR
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N200677
Product Number: 003
Approval Date: Dec 14, 2012
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information