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Details for New Drug Application (NDA): 019221

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NDA 019221 describes VASERETIC, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from two suppliers. Additional details are available on the VASERETIC profile page.

The generic ingredient in VASERETIC is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for NDA: 019221

Tradename:
VASERETIC
Applicant:
Valeant Intl
Ingredient:
enalapril maleate; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019221

Suppliers and Packaging for NDA: 019221

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 019221 NDA Valeant Pharmaceuticals North America LLC 0187-0146 0187-0146-01 100 TABLET in 1 BOTTLE (0187-0146-01)
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 019221 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-146 68682-146-01 100 TABLET in 1 BOTTLE (68682-146-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;25MG
Approval Date:Oct 31, 1986TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG
Approval Date:Jul 12, 1995TE:ABRLD:No

Expired Orange Book Patents for NDA: 019221

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL019221-003Jul 12, 19954,374,829*PED► subscribe
Valeant Intl
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL019221-001Oct 31, 19864,472,380*PED► subscribe
Valeant Intl
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL019221-001Oct 31, 19864,374,829*PED► subscribe
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