Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022074

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SOMATULINE DEPOT (LANREOTIDE ACETATE)
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) Marketing Status: Prescription

Active Ingredient: LANREOTIDE ACETATE
Proprietary Name: SOMATULINE DEPOT
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022074
Product Number: 001
Approval Date: Aug 30, 2007
Applicant Holder Full Name: IPSEN PHARMA BIOTECH SAS
Marketing Status:  Prescription
Patent and Exclusivity Information

SOMATULINE DEPOT (LANREOTIDE ACETATE)
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) Marketing Status: Prescription

Active Ingredient: LANREOTIDE ACETATE
Proprietary Name: SOMATULINE DEPOT
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022074
Product Number: 002
Approval Date: Aug 30, 2007
Applicant Holder Full Name: IPSEN PHARMA BIOTECH SAS
Marketing Status:  Prescription
Patent and Exclusivity Information

SOMATULINE DEPOT (LANREOTIDE ACETATE)
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) Marketing Status: Prescription

Active Ingredient: LANREOTIDE ACETATE
Proprietary Name: SOMATULINE DEPOT
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022074
Product Number: 003
Approval Date: Aug 30, 2007
Applicant Holder Full Name: IPSEN PHARMA BIOTECH SAS
Marketing Status:  Prescription
Patent and Exclusivity Information

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