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Details for New Drug Application (NDA): 022074

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NDA 022074 describes SOMATULINE DEPOT, which is a drug marketed by Ipsen Pharma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SOMATULINE DEPOT profile page.

The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lanreotide acetate profile page.

Summary for NDA: 022074

Tradename:
SOMATULINE DEPOT
Applicant:
Ipsen Pharma
Ingredient:
lanreotide acetate
Patents:1
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)

Pharmacology for NDA: 022074

Suppliers and Packaging for NDA: 022074

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOMATULINE DEPOT
lanreotide acetate
SOLUTION;SUBCUTANEOUS 022074 NDA Ipsen Biopharmaceuticals, Inc. 15054-0060 15054-0060-1 1 POUCH in 1 CARTON (15054-0060-1) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE
SOMATULINE DEPOT
lanreotide acetate
SOLUTION;SUBCUTANEOUS 022074 NDA Ipsen Biopharmaceuticals, Inc. 15054-0090 15054-0090-1 1 POUCH in 1 CARTON (15054-0090-1) > 1 SYRINGE in 1 POUCH > .3 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
Approval Date:Aug 30, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2017
Regulatory Exclusivity Use:FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE, WELL-OR MODERATELY-DIFFERENTIATED, LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) TO IMPROVE PROGRESSIONFREE SURVIVAL.
Patent:5,595,760Patent Expiration:Mar 8, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING LANREOTIDE ACETATE
Regulatory Exclusivity Expiration:Dec 16, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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