Details for New Drug Application (NDA): 076704
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The generic ingredient in METOPROLOL TARTRATE 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 076704
Tradename: | METOPROLOL TARTRATE |
Applicant: | Mylan |
Ingredient: | metoprolol tartrate |
Patents: | 0 |
Pharmacology for NDA: 076704
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 076704
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE | metoprolol tartrate | TABLET;ORAL | 076704 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0018 | 0378-0018-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0018-01) |
METOPROLOL TARTRATE | metoprolol tartrate | TABLET;ORAL | 076704 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0018 | 0378-0018-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0018-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jan 16, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jan 16, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jan 16, 2004 | TE: | AB | RLD: | No |
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