Details for New Drug Application (NDA): 202811
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The generic ingredient in LINZESS is linaclotide. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linaclotide profile page.
Summary for 202811
Tradename: | LINZESS |
Applicant: | Allergan |
Ingredient: | linaclotide |
Patents: | 12 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202811
Mechanism of Action | Guanylate Cyclase Activators |
Suppliers and Packaging for NDA: 202811
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINZESS | linaclotide | CAPSULE;ORAL | 202811 | NDA | Allergan, Inc. | 0456-1201 | 0456-1201-04 | 1 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE |
LINZESS | linaclotide | CAPSULE;ORAL | 202811 | NDA | Allergan, Inc. | 0456-1201 | 0456-1201-30 | 1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 145MCG | ||||
Approval Date: | Aug 30, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 30, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS. | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 30, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 28, 2024 | Product Flag? | Substance Flag? | Y | Delist Request? |
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