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Serving 500+ biopharmaceutical companies globally:

Colorcon
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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040615

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NDA 040615 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: 040615

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: 040615

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 040615

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE CYPIONATE
testosterone cypionate
INJECTABLE;INJECTION 040615 ANDA Physicians Total Care, Inc. 54868-3669 54868-3669-0 1 VIAL, MULTI-DOSE in 1 CARTON (54868-3669-0) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Aug 10, 2006TE:AORLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Aug 10, 2006TE:AORLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
US Army
AstraZeneca
Cipla
Medtronic
Daiichi Sankyo
US Department of Justice
Cantor Fitzgerald
Cerilliant
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.

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