Details for New Drug Application (NDA): 018303
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NDA 018303 describes LOPRESSOR HCT, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LOPRESSOR HCT profile page.
The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 018303
| Tradename: | LOPRESSOR HCT |
| Applicant: | Validus Pharms |
| Ingredient: | hydrochlorothiazide; metoprolol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 018303
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 018303
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303 | NDA | Validus Pharmaceuticals LLC | 30698-461 | 30698-461-01 | 100 TABLET in 1 BOTTLE (30698-461-01) |
| LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303 | NDA | Validus Pharmaceuticals LLC | 30698-462 | 30698-462-01 | 100 TABLET in 1 BOTTLE (30698-462-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;50MG | ||||
| Approval Date: | Dec 31, 1984 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 31, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 31, 1984 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 018303
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Validus Pharms | LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303-003 | Dec 31, 1984 | 3,876,802 | ⤷ Subscribe |
| Validus Pharms | LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303-001 | Dec 31, 1984 | 3,876,802 | ⤷ Subscribe |
| Validus Pharms | LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303-003 | Dec 31, 1984 | 3,998,790 | ⤷ Subscribe |
| Validus Pharms | LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303-002 | Dec 31, 1984 | 3,998,790 | ⤷ Subscribe |
| Validus Pharms | LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303-002 | Dec 31, 1984 | 3,876,802 | ⤷ Subscribe |
| Validus Pharms | LOPRESSOR HCT | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 018303-001 | Dec 31, 1984 | 3,998,790 | ⤷ Subscribe |
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