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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217193


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NDA 217193 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 217193
Tradename:LANREOTIDE ACETATE
Applicant:Invagen Pharms
Ingredient:lanreotide acetate
Patents:0
Pharmacology for NDA: 217193
Mechanism of ActionSomatostatin Receptor Agonists
Suppliers and Packaging for NDA: 217193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 217193 ANDA Cipla USA Inc. 69097-906 69097-906-67 1 POUCH in 1 CARTON (69097-906-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE
LANREOTIDE ACETATE lanreotide acetate SOLUTION;SUBCUTANEOUS 217193 ANDA Cipla USA Inc. 69097-907 69097-907-67 1 POUCH in 1 CARTON (69097-907-67) / 1 SYRINGE in 1 POUCH / .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:May 21, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
Approval Date:May 21, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
Approval Date:May 21, 2024TE:ABRLD:No

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Preferred Citation:

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