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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 215395


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NDA 215395 describes LANREOTIDE ACETATE, which is a drug marketed by Invagen Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the LANREOTIDE ACETATE profile page.

The generic ingredient in LANREOTIDE ACETATE is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.
Summary for 215395
Tradename:LANREOTIDE ACETATE
Applicant:Invagen Pharms
Ingredient:lanreotide acetate
Patents:0
Pharmacology for NDA: 215395
Mechanism of ActionSomatostatin Receptor Agonists
Suppliers and Packaging for NDA: 215395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 215395 NDA Cipla USA Inc. 69097-870 69097-870-67 1 SYRINGE in 1 CARTON (69097-870-67) / .5 mL in 1 SYRINGE
LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 215395 NDA Cipla USA Inc. 69097-880 69097-880-67 1 SYRINGE in 1 CARTON (69097-880-67) / .2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
Approval Date:Dec 17, 2021TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
Approval Date:Dec 17, 2021TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
Approval Date:Dec 17, 2021TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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