Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Merck
Mallinckrodt
Moodys
McKinsey

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079198

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 079198 describes OCTREOTIDE ACETATE (PRESERVATIVE FREE), which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, 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 twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 079198
Tradename:OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Applicant:Mylan Institutional
Ingredient:octreotide acetate
Patents:0
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 67457-239-01 10 SYRINGE in 1 CARTON (67457-239-01) > 1 mL in 1 SYRINGE (67457-239-00)
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198 ANDA Mylan Institutional LLC 67457-245 67457-245-01 10 SYRINGE in 1 CARTON (67457-245-01) > 1 mL in 1 SYRINGE (67457-245-00)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Harvard Business School
McKesson
Baxter
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.