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Details for New Drug Application (NDA): 020364

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NDA 020364 describes LOTREL, which is a drug marketed by Novartis and is included in one NDA. It is available from eight suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the LOTREL profile page.

The generic ingredient in LOTREL is amlodipine besylate; benazepril hydrochloride. There are forty-nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

Summary for NDA: 020364

Tradename:
LOTREL
Applicant:
Novartis
Ingredient:
amlodipine besylate; benazepril hydrochloride
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020364

Suppliers and Packaging for NDA: 020364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL 020364 NDA Novartis Pharmaceuticals Corporation 0078-0364 0078-0364-05 100 CAPSULE in 1 BOTTLE (0078-0364-05)
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL 020364 NDA Novartis Pharmaceuticals Corporation 0078-0379 0078-0379-05 100 CAPSULE in 1 BOTTLE (0078-0379-05)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2.5MG BASE;10MG
Approval Date:Mar 3, 1995TE:ABRLD:No
Patent:6,162,802Patent Expiration:Dec 19, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CARDIOVASCULAR DISORDERS

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;10MG
Approval Date:Mar 3, 1995TE:ABRLD:No
Patent:6,162,802Patent Expiration:Dec 19, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CARDIOVASCULAR DISORDERS

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;20MG
Approval Date:Mar 3, 1995TE:ABRLD:No
Patent:6,162,802Patent Expiration:Dec 19, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CARDIOVASCULAR DISORDERS

Expired Orange Book Patents for NDA: 020364

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-005Jun 20, 20024,410,520*PED► subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-002Mar 3, 19954,410,520*PED► subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-003Mar 3, 19954,572,909► subscribe
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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.

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