Details for New Drug Application (NDA): 204205
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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 204205
Tradename: | METOPROLOL TARTRATE |
Applicant: | Gland Pharma Ltd |
Ingredient: | metoprolol tartrate |
Patents: | 0 |
Pharmacology for NDA: 204205
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 204205
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE | metoprolol tartrate | INJECTABLE;INJECTION | 204205 | ANDA | Sagent Pharmaceuticals | 25021-303 | 25021-303-05 | 10 VIAL in 1 CARTON (25021-303-05) / 5 mL in 1 VIAL |
METOPROLOL TARTRATE | metoprolol tartrate | INJECTABLE;INJECTION | 204205 | ANDA | Cardinal Health 107, LLC | 55154-1557 | 55154-1557-5 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-1557-5) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | Aug 27, 2014 | TE: | AP | RLD: | No |
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