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Serving 500+ biopharmaceutical companies globally:

Baxter
Moodys
Harvard Business School
Federal Trade Commission
Dow
UBS
Johnson and Johnson
US Army
Argus Health
Mallinckrodt

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203253

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NDA 203253 describes SPIRONOLACTONE, which is a drug marketed by Ivax Pharms, Sandoz, Accord Hlthcare, Mylan, Sun Pharm Inds, Amneal Pharms, Lederle, Vangard, Vintage, Warner Chilcott, Actavis Elizabeth, Jubilant Generics, Purepac Pharm, Upsher Smith, Superpharm, Mutual Pharm, Watson Labs, Ascot, Orion Corp Orion, Parke Davis, and Usl Pharma, and is included in thirty-nine NDAs. It is available from thirty-eight 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 NDA: 203253

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

Pharmacology for NDA: 203253

Mechanism of ActionAldosterone Antagonists

Suppliers and Packaging for NDA: 203253

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE
spironolactone
TABLET;ORAL 203253 ANDA Aidarex Pharmaceuticals LLC 53217-240 53217-240-30 30 TABLET, FILM COATED in 1 BOTTLE (53217-240-30)
SPIRONOLACTONE
spironolactone
TABLET;ORAL 203253 ANDA Aidarex Pharmaceuticals LLC 53217-240 53217-240-60 60 TABLET, FILM COATED in 1 BOTTLE (53217-240-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 23, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 23, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 23, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Novartis
Daiichi Sankyo
Chubb
Citi
Federal Trade Commission
Moodys
Fish and Richardson
Chinese Patent Office
McKinsey
Cerilliant

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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