Details for New Drug Application (NDA): 076792
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The generic ingredient in METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE 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 076792
Tradename: | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE |
Applicant: | Mylan |
Ingredient: | hydrochlorothiazide; metoprolol tartrate |
Patents: | 0 |
Pharmacology for NDA: 076792
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 076792
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 076792 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0424 | 0378-0424-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0424-01) |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; metoprolol tartrate | TABLET;ORAL | 076792 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0434 | 0378-0434-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0434-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;50MG | ||||
Approval Date: | Aug 20, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Aug 20, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;100MG | ||||
Approval Date: | Aug 20, 2004 | TE: | AB | RLD: | No |
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