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Details for New Drug Application (NDA): 079245

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NDA 079245 describes FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Mylan, Actavis Labs Fl Inc, Emcure Pharms India, Invagen Pharms, Sun Pharm Inds Ltd, Watson Labs, Aurobindo Pharma, Teva, and Sandoz, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

Summary for NDA: 079245

Tradename:
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Applicant:
Aurobindo Pharma
Ingredient:
fosinopril sodium; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 079245

Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 079245

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
fosinopril sodium; hydrochlorothiazide
TABLET;ORAL 079245 ANDA Citron Pharma LLC 57237-026 57237-026-01 100 TABLET in 1 BOTTLE (57237-026-01)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
fosinopril sodium; hydrochlorothiazide
TABLET;ORAL 079245 ANDA Citron Pharma LLC 57237-026 57237-026-30 30 TABLET in 1 BOTTLE (57237-026-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:Jul 9, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;12.5MG
Approval Date:Jul 9, 2009TE:ABRLD:No


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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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