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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Queensland Health
Fish and Richardson
US Army

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079198

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NDA 079198 describes OCTREOTIDE ACETATE (PRESERVATIVE FREE), which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms, and West-ward Pharms Int, and is included in four NDAs. It is available from four suppliers. Additional details are available on the OCTREOTIDE ACETATE (PRESERVATIVE FREE) profile page.

The generic ingredient in OCTREOTIDE ACETATE (PRESERVATIVE FREE) is octreotide acetate. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 079198
Applicant:Mylan Institutional
Ingredient:octreotide acetate
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Pharmacology for NDA: 079198
Medical Subject Heading (MeSH) Categories for 079198
Suppliers and Packaging for NDA: 079198
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198 ANDA Mylan Institutional LLC 67457-239 N 67457-239-01
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198 ANDA Mylan Institutional LLC 67457-245 N 67457-245-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Feb 10, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML
Approval Date:Feb 10, 2011TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Feb 10, 2011TE:APRLD:No

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