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Serving leading biopharmaceutical companies globally:

Cerilliant
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040353

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NDA 040353 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-one 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 040353
Tradename:SPIRONOLACTONE
Applicant:Actavis Elizabeth
Ingredient:spironolactone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040353
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 040353
Suppliers and Packaging for NDA: 040353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE spironolactone TABLET;ORAL 040353 ANDA Actavis Pharma, Inc. 0228-2672 0228-2672-50 500 TABLET, FILM COATED in 1 BOTTLE (0228-2672-50)
SPIRONOLACTONE spironolactone TABLET;ORAL 040353 ANDA Actavis Pharma, Inc. 0228-2672 0228-2672-11 100 TABLET, FILM COATED in 1 BOTTLE (0228-2672-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 29, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 29, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 15, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Federal Trade Commission
Cerilliant

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