Details for New Drug Application (NDA): 076792
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NDA 076792 describes METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Mylan, Senores Pharms, and Sun Pharm Inds, and is included in four NDAs. It is available from five suppliers. Additional details are available on the METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
The generic ingredient in METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Six 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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