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:

AstraZeneca
Baxter
Colorcon
McKesson
McKinsey
Dow

Last Updated: November 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077457

See Plans and Pricing

« Back to Dashboard

NDA 077457 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 077457
Tradename:OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Applicant:Fresenius Kabi Usa
Ingredient:octreotide acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077457
Medical Subject Heading (MeSH) Categories for 077457
Suppliers and Packaging for NDA: 077457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457 ANDA Fresenius Kabi USA, LLC 63323-376 63323-376-01 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-01) > 1 mL in 1 VIAL, SINGLE-DOSE
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457 ANDA Fresenius Kabi USA, LLC 63323-376 63323-376-04 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-04) > 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Express Scripts
Mallinckrodt
Harvard Business School
Boehringer Ingelheim

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.