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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202975

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NDA 202975 describes DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Anchen Pharms and Actavis Labs Fl Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE profile page.

The generic ingredient in DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE is dutasteride; tamsulosin hydrochloride. There are seventeen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for NDA: 202975

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 202975

Suppliers and Packaging for NDA: 202975

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL 202975 ANDA Actavis Pharma, Inc. 0591-3771 0591-3771-19 90 CAPSULE in 1 BOTTLE (0591-3771-19)
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL 202975 ANDA Actavis Pharma, Inc. 0591-3771 0591-3771-30 30 CAPSULE in 1 BOTTLE (0591-3771-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG;0.4MG
Approval Date:Nov 20, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Queensland Health
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US Department of Justice
Citi
Fuji
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Fish and Richardson
Medtronic

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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