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Generated: January 23, 2019

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Details for New Drug Application (NDA): 017963

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NDA 017963 describes LOPRESSOR, which is a drug marketed by Novartis and Us Pharms Holdings I and is included in four NDAs. It is available from one supplier. Additional details are available on the LOPRESSOR profile page.

The generic ingredient in LOPRESSOR 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 017963
Tradename:LOPRESSOR
Applicant:Us Pharms Holdings I
Ingredient:metoprolol tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017963
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 017963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPRESSOR metoprolol tartrate TABLET;ORAL 017963 NDA Validus Pharmaceuticals LLC 30698-458 30698-458-01 100 TABLET in 1 BOTTLE (30698-458-01)
LOPRESSOR metoprolol tartrate TABLET;ORAL 017963 NDA Validus Pharmaceuticals LLC 30698-459 30698-459-01 100 TABLET in 1 BOTTLE (30698-459-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017963

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharms Holdings I LOPRESSOR metoprolol tartrate TABLET;ORAL 017963-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOPRESSOR metoprolol tartrate TABLET;ORAL 017963-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOPRESSOR metoprolol tartrate TABLET;ORAL 017963-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOPRESSOR metoprolol tartrate TABLET;ORAL 017963-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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