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Details for New Drug Application (NDA): 018704

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NDA 018704 describes LOPRESSOR, which is a drug marketed by Novartis and Us Pharms Holdings I and is included in four NDAs. It is available from three suppliers. Additional details are available on the LOPRESSOR profile page.

The generic ingredient in LOPRESSOR is hydrochlorothiazide; metoprolol tartrate. There are thirty-one 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 NDA: 018704

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018704

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 018704

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metoprolol tartrate
INJECTABLE;INJECTION 018704 NDA Novartis Pharmaceuticals Corporation 0078-0400 0078-0400-01 10 AMPULE in 1 CARTON (0078-0400-01) > 5 mL in 1 AMPULE (0078-0400-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Mar 30, 1984TE:APRLD:Yes

Expired Orange Book Patents for NDA: 018704

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
metoprolol tartrate
INJECTABLE;INJECTION018704-001Mar 30, 19843,876,802► Subscribe
metoprolol tartrate
INJECTABLE;INJECTION018704-001Mar 30, 19843,998,790► Subscribe
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