Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202811

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LINZESS (LINACLOTIDE)
72MCG
Marketing Status: Prescription
Active Ingredient: LINACLOTIDE
Proprietary Name: LINZESS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 72MCG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202811
Product Number: 003
Approval Date: Jan 25, 2017
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LINZESS (LINACLOTIDE)
145MCG
Marketing Status: Prescription
Active Ingredient: LINACLOTIDE
Proprietary Name: LINZESS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 145MCG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202811
Product Number: 001
Approval Date: Aug 30, 2012
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LINZESS (LINACLOTIDE)
290MCG
Marketing Status: Prescription
Active Ingredient: LINACLOTIDE
Proprietary Name: LINZESS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 290MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202811
Product Number: 002
Approval Date: Aug 30, 2012
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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