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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Merck
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Fuji
Cantor Fitzgerald
Deloitte
Daiichi Sankyo

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089424

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NDA 089424 describes SPIRONOLACTONE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Orion Corp Orion, Purepac Pharm, Sandoz, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Vintage, Warner Chilcott, Watson Labs, Parke Davis, and Usl Pharma, and is included in thirty-nine NDAs. It is available from forty suppliers. Additional details are available on the SPIRONOLACTONE profile page.

The generic ingredient in SPIRONOLACTONE is hydrochlorothiazide; spironolactone. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

Summary for 089424

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 089424

Mechanism of ActionAldosterone Antagonists

Suppliers and Packaging for NDA: 089424

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 089424 ANDA Rebel Distributors Corp 21695-766 21695-766-30 30 TABLET in 1 BOTTLE, PLASTIC (21695-766-30)
SPIRONOLACTONE spironolactone TABLET;ORAL 089424 ANDA A-S Medication Solutions 50090-0136 50090-0136-0 100 TABLET in 1 BOTTLE, PLASTIC (50090-0136-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 23, 1986TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 11, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 11, 1999TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
US Department of Justice
Chubb
Express Scripts
Merck
Accenture
Argus Health
Cipla
AstraZeneca

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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