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Serving 500+ biopharmaceutical companies globally:

Medtronic
Accenture
Harvard Business School
Moodys
Cantor Fitzgerald
Express Scripts
UBS
Boehringer Ingelheim
Baxter
Fuji

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040750

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NDA 040750 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: 040750

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

Pharmacology for NDA: 040750

Mechanism of ActionAldosterone Antagonists

Suppliers and Packaging for NDA: 040750

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE
spironolactone
 TABLET;ORAL 040750 ANDA Qualitest Pharmaceuticals 0603-5763 0603-5763-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-21)
SPIRONOLACTONE
spironolactone
 TABLET;ORAL 040750 ANDA Qualitest Pharmaceuticals 0603-5763 0603-5763-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Aug 29, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 29, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 29, 2006TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Moodys
McKinsey
Novartis
Johnson and Johnson
US Army
Julphar
Mallinckrodt
US Department of Justice
Teva
Dow

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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