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Serving 500+ biopharmaceutical companies globally:

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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086030

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NDA 086030 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Watson Labs, Sandoz Inc, Sun Pharm Inds Ltd, Paddock Llc, Watson Pharms Inc, Luitpold Pharms Inc, Hikma Farmaceutica, Mylan Institutional, and West-ward Pharms Int, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the TESTOSTERONE CYPIONATE profile page.

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

Summary for NDA: 086030

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: 086030

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 086030

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE
testosterone cypionate
INJECTABLE;INJECTION 086030 ANDA Dispensing Solutions, Inc. 55045-2092 55045-2092-2 1 VIAL, MULTI-DOSE in 1 CARTON (55045-2092-2) > 10 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 500+ biopharmaceutical companies globally:

Cerilliant
QuintilesIMS
Harvard Business School
Teva
McKesson
Daiichi Sankyo
Federal Trade Commission
US Department of Justice
Fuji
Fish and Richardson

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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