Details for New Drug Application (NDA): 019221
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NDA 019221 describes VASERETIC, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. 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. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
The generic ingredient in VASERETIC is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 019221
| Tradename: | VASERETIC |
| Applicant: | Bausch |
| Ingredient: | enalapril maleate; hydrochlorothiazide |
| Patents: | 0 |
Pharmacology for NDA: 019221
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure Increased Diuresis |
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 | Bausch Health US, LLC | 0187-0146 | 0187-0146-01 | 100 TABLET in 1 BOTTLE (0187-0146-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;25MG | ||||
| Approval Date: | Oct 31, 1986 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;12.5MG | ||||
| Approval Date: | Jul 12, 1995 | TE: | AB | RLD: | Yes | ||||
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