Details for New Drug Application (NDA): 020033
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The generic ingredient in LOTENSIN HCT is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 020033
Tradename: | LOTENSIN HCT |
Applicant: | Validus Pharms |
Ingredient: | benazepril hydrochloride; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 020033
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Suppliers and Packaging for NDA: 020033
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOTENSIN HCT | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 020033 | NDA AUTHORIZED GENERIC | Padagis US LLC | 0574-0227 | 0574-0227-01 | 100 TABLET in 1 BOTTLE (0574-0227-01) |
LOTENSIN HCT | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 020033 | NDA AUTHORIZED GENERIC | Padagis US LLC | 0574-0228 | 0574-0228-01 | 100 TABLET in 1 BOTTLE (0574-0228-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 19, 1992 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;12.5MG | ||||
Approval Date: | May 19, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG;25MG | ||||
Approval Date: | May 19, 1992 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020033
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Validus Pharms | LOTENSIN HCT | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 020033-003 | May 19, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | LOTENSIN HCT | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 020033-001 | May 19, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | LOTENSIN HCT | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 020033-004 | May 19, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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