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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203255

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SIGNIFOR LAR KIT (PASIREOTIDE PAMOATE)
EQ 10MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PASIREOTIDE PAMOATE
Proprietary Name: SIGNIFOR LAR KIT
Dosage Form; Route of Administration: FOR SUSPENSION; INTRAMUSCULAR
Strength: EQ 10MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203255
Product Number: 004
Approval Date: Jun 29, 2018
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SIGNIFOR LAR KIT (PASIREOTIDE PAMOATE)
EQ 20MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PASIREOTIDE PAMOATE
Proprietary Name: SIGNIFOR LAR KIT
Dosage Form; Route of Administration: FOR SUSPENSION; INTRAMUSCULAR
Strength: EQ 20MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203255
Product Number: 001
Approval Date: Dec 15, 2014
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SIGNIFOR LAR KIT (PASIREOTIDE PAMOATE)
EQ 30MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PASIREOTIDE PAMOATE
Proprietary Name: SIGNIFOR LAR KIT
Dosage Form; Route of Administration: FOR SUSPENSION; INTRAMUSCULAR
Strength: EQ 30MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203255
Product Number: 005
Approval Date: Jun 29, 2018
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SIGNIFOR LAR KIT (PASIREOTIDE PAMOATE)
EQ 40MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PASIREOTIDE PAMOATE
Proprietary Name: SIGNIFOR LAR KIT
Dosage Form; Route of Administration: FOR SUSPENSION; INTRAMUSCULAR
Strength: EQ 40MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203255
Product Number: 002
Approval Date: Dec 15, 2014
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SIGNIFOR LAR KIT (PASIREOTIDE PAMOATE)
EQ 60MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PASIREOTIDE PAMOATE
Proprietary Name: SIGNIFOR LAR KIT
Dosage Form; Route of Administration: FOR SUSPENSION; INTRAMUSCULAR
Strength: EQ 60MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203255
Product Number: 003
Approval Date: Dec 15, 2014
Applicant Holder Full Name: RECORDATI RARE DISEASES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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