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Serving leading biopharmaceutical companies globally:

Chubb
AstraZeneca
Colorcon
Citi
Novartis
Deloitte
Daiichi Sankyo
Teva
Julphar
McKinsey

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076330

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NDA 076330 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional, and is included in sixteen NDAs. It is available from six suppliers. Additional details are available on the OCTREOTIDE ACETATE profile page.

The generic ingredient in OCTREOTIDE ACETATE is octreotide acetate. There are eighteen 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 076330
Tradename:OCTREOTIDE ACETATE
Applicant:West-ward Pharms Int
Ingredient:octreotide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Pharmacology for NDA: 076330
Medical Subject Heading (MeSH) Categories for 076330
Suppliers and Packaging for NDA: 076330
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 076330 ANDA West-Ward Pharmaceuticals Corp. 0641-6177 0641-6177-01 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6177-01) > 5 mL in 1 VIAL, MULTI-DOSE
OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 076330 ANDA West-Ward Pharmaceuticals Corp. 0641-6178 0641-6178-01 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6178-01) > 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.2MG BASE/ML
Approval Date:Apr 8, 2005TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Apr 8, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
US Department of Justice
UBS
Federal Trade Commission
Daiichi Sankyo
Fish and Richardson
Healthtrust
Medtronic
Citi

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