Details for New Drug Application (NDA): 215395

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 Action

Somatostatin 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:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
Approval Date:	Dec 17, 2021	TE:		RLD:	Yes

Profile for product number 002

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

Profile for product number 003

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

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