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Details for New Drug Application (NDA): 018303

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NDA 018303 describes LOPRESSOR HCT, which is a drug marketed by Us Pharms Holdings I and is included in one NDA. It is available from one supplier. Additional details are available on the LOPRESSOR HCT profile page.

The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for NDA: 018303

Pharmacology for NDA: 018303

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 018303

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrochlorothiazide; metoprolol tartrate
TABLET;ORAL 018303 NDA Validus Pharmaceuticals LLC 30698-460 30698-460-01 100 TABLET in 1 BOTTLE (30698-460-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;50MG
Approval Date:Dec 31, 1984TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Dec 31, 1984TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG;100MG
Approval Date:Dec 31, 1984TE:RLD:No

Expired Orange Book Patents for NDA: 018303

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharms Holdings I
hydrochlorothiazide; metoprolol tartrate
TABLET;ORAL018303-003Dec 31, 19843,876,802<disabled>
Us Pharms Holdings I
hydrochlorothiazide; metoprolol tartrate
TABLET;ORAL018303-001Dec 31, 19843,876,802<disabled>
Us Pharms Holdings I
hydrochlorothiazide; metoprolol tartrate
TABLET;ORAL018303-002Dec 31, 19843,876,802<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.