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Details for New Drug Application (NDA): 018063

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NDA 018063 describes CORGARD, which is a drug marketed by Us Worldmeds Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the CORGARD profile page.

The generic ingredient in CORGARD is nadolol. There are four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nadolol profile page.

Summary for NDA: 018063

Us Worldmeds Llc
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 018063

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 018063

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 018063 NDA US WorldMeds, LLC 27505-100 27505-100-01 100 TABLET in 1 BOTTLE (27505-100-01)
TABLET;ORAL 018063 NDA US WorldMeds, LLC 27505-101 27505-101-01 100 TABLET in 1 BOTTLE (27505-101-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength120MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018063

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Worldmeds Llc
TABLET;ORAL018063-002Approved Prior to Jan 1, 19823,935,267<disabled>
Us Worldmeds Llc
TABLET;ORAL018063-005Oct 28, 19863,935,267<disabled>
Us Worldmeds Llc
TABLET;ORAL018063-003Approved Prior to Jan 1, 19823,982,021<disabled>
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