Details for New Drug Application (NDA): 077761
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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 077761
Tradename: | METOPROLOL TARTRATE |
Applicant: | Hikma Farmaceutica |
Ingredient: | metoprolol tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077761
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 077761
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE | metoprolol tartrate | INJECTABLE;INJECTION | 077761 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9660 | 0143-9660-10 | 10 VIAL in 1 CARTON (0143-9660-10) / 5 mL in 1 VIAL (0143-9660-01) |
METOPROLOL TARTRATE | metoprolol tartrate | INJECTABLE;INJECTION | 077761 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9873 | 0143-9873-10 | 5 mL in 1 VIAL (0143-9873-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | May 30, 2007 | TE: | AP | RLD: | No |
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