Details for New Drug Application (NDA): 075788
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The generic ingredient in ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE 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 075788
Tradename: | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE |
Applicant: | Taro Pharm Inds |
Ingredient: | enalapril maleate; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 075788
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Suppliers and Packaging for NDA: 075788
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 075788 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4045 | 51672-4045-1 | 100 TABLET in 1 BOTTLE (51672-4045-1) |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 075788 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4045 | 51672-4045-3 | 1000 TABLET in 1 BOTTLE (51672-4045-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;12.5MG | ||||
Approval Date: | Sep 18, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;25MG | ||||
Approval Date: | Sep 18, 2001 | TE: | AB | RLD: | No |
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