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Details for New Drug Application (NDA): 018118

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NDA 018118 describes LANOXICAPS, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. Additional details are available on the LANOXICAPS profile page.

The generic ingredient in LANOXICAPS is digoxin. There are ten drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for NDA: 018118

Tradename:
LANOXICAPS
Applicant:
Glaxosmithkline Llc
Ingredient:
digoxin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.2MG
Approval Date:Jul 26, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.05MG
Approval Date:Jul 26, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.1MG
Approval Date:Jul 26, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018118

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
LANOXICAPS
digoxin
CAPSULE;ORAL018118-002Jul 26, 19824,088,750► subscribe
Glaxosmithkline Llc
LANOXICAPS
digoxin
CAPSULE;ORAL018118-001Jul 26, 19824,088,750► subscribe
Glaxosmithkline Llc
LANOXICAPS
digoxin
CAPSULE;ORAL018118-004Sep 24, 19844,088,750► subscribe
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