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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Fish and Richardson
Cipla
UBS
Dow
Farmers Insurance
Queensland Health
Chubb
Fuji

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085598

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NDA 085598 describes TESTOSTERONE ENANTHATE, which is a drug marketed by Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Watson Labs, and Watson Pharms Inc, and is included in eight NDAs. It is available from two suppliers. Additional details are available on the TESTOSTERONE ENANTHATE profile page.

The generic ingredient in TESTOSTERONE ENANTHATE is estradiol valerate; testosterone enanthate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol valerate; testosterone enanthate profile page.

Summary for 085598

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 085598

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 085598

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 085598 ANDA Actavis Pharma, Inc. 0591-3221 0591-3221-26 1 VIAL, MULTI-DOSE in 1 CARTON (0591-3221-26) > 5 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AORLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Boehringer Ingelheim
Covington
Teva
McKinsey
Deloitte
Fish and Richardson
Colorcon
Harvard Business School

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.

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